A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UNIFI)

• ClinicalTrials.gov Identifier: NCT02407236
• Recruitment Status: Completed
• First Posted: April 2, 2015
• Results First Posted: December 23, 2019
• Last Update Posted: January 5, 2023
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Investigator)
• Conditions: Colitis, Ulcerative; Inflammatory Bowel Diseases
• Interventions: Drug: Placebo IV; Drug: Placebo SC; Drug: Ustekinumab IV; Drug: Ustekinumab SC
• Enrollment: 961

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Induction Study(IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6mg/kg IV	Maintenance Study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90mg SC Every 8 Weeks (q8w)	MS: Placebo IV (IS - Responders) to Placebo SC	MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w	Long Term Extension (LTE): Placebo SC	LTE: Ustekinumab 90 mg SC q12w	LTE: Ustekinumab 90 mg SC q8w	LTE: Placebo IV (IS - Responders) to Placebo SC	LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w
Arm/Group Description	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab who were randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.	Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	Participants who were randomized to receive placebo SC in the maintenance study and received placebo SC at the first dosing visit (Week 48) of long term extension (LTE).	Participants who were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.	Participants who were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.	Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC in the maintenance study and the LTE through Week 200 (non-randomized participants).	Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC q8w in the maintenance study and the LTE through Week 200 (non-randomized participants).
Period Title: Induction Study (8 Weeks)
Started	319	320	322	0	0	0	0	0	0	0	0	0	0
Completed	296	309	307	0	0	0	0	0	0	0	0	0	0
Not Completed	23	11	15	0	0	0	0	0	0	0	0	0	0
Reason Not Completed
Adverse Event	3	0	1	0	0	0	0	0	0	0	0	0	0
Death	0	0	1	0	0	0	0	0	0	0	0	0	0
Withdrawal by Subject	17	9	7	0	0	0	0	0	0	0	0	0	0
Lack of Efficacy	0	0	1	0	0	0	0	0	0	0	0	0	0
Physician Decision	1	1	0	0	0	0	0	0	0	0	0	0	0
Other	2	1	5	0	0	0	0	0	0	0	0	0	0
Period Title: Maintenance Study (44 Weeks)
Started	0	0	0	175	172	176	103	157	0	0	0	0	0
Completed	0	0	0	132	148	158	76	128	0	0	0	0	0
Not Completed	0	0	0	43	24	18	27	29	0	0	0	0	0
Reason Not Completed
Adverse Event	0	0	0	19	8	4	11	10	0	0	0	0	0
Lack of Efficacy	0	0	0	19	9	6	12	12	0	0	0	0	0
Other	0	0	0	5	7	8	4	6	0	0	0	0	0
Death	0	0	0	0	0	0	0	1	0	0	0	0	0
Period Title: Long-term Extension Period (176 Weeks)
Started	0	0	0	0	0	0	0	0	115	141	143	73	116
Completed	0	0	0	0	0	0	0	0	34	99	101	0	95
Not Completed	0	0	0	0	0	0	0	0	81	42	42	73	21
Reason Not Completed
Adverse Event	0	0	0	0	0	0	0	0	9	17	10	11	9
Lost to Follow-up	0	0	0	0	0	0	0	0	0	0	1	0	0
Lack of Efficacy	0	0	0	0	0	0	0	0	9	6	12	7	6
Other	0	0	0	0	0	0	0	0	63	19	19	55	6

Baseline Characteristics

Arm/Group Title		Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6mg/kg IV	Maintenance Study(MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90mg SC Every 8 Weeks (q8w)	MS: Placebo IV (IS - Responders) to Placebo SC	MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w	Long Term Extension (LTE): Placebo SC	LTE: Ustekinumab 90 mg SC q12w	LTE: Ustekinumab 90 mg SC q8w	LTE: Placebo IV (IS - Responders) to Placebo SC	LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w	Total
Arm/Group Description		Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab who were randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.	Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).	Participants who were randomized to receive placebo SC in the maintenance study and received placebo SC at the first dosing visit (Week 48) of long term extension (LTE).	Participants who were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.	Participants who were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.	Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC in the maintenance study and the LTE through Week 200 (non-randomized participants).	Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC q8w in the maintenance study and the LTE through Week 200 (non-randomized participants).	Total of all reporting groups
Overall Number of Baseline Participants		319	320	322	0	0	0	0	0	0	0	0	0	0	961
Baseline Analysis Population Description		The primary efficacy analysis set consisted of all participants randomized in the study.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	319 participants	320 participants	322 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	961 participants
		41.2 (13.50)	42.2 (13.94)	41.7 (13.67)											41.7 (13.70)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	319 participants	320 participants	322 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	961 participants
	Female	122 38.2%	130 40.6%	127 39.4%	0	0	0	0	0	0	0	0	0	0	379 39.4%
	Male	197 61.8%	190 59.4%	195 60.6%	0	0	0	0	0	0	0	0	0	0	582 60.6%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	319 participants	320 participants	322 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	961 participants
	Hispanic or Latino	10 3.1%	7 2.2%	7 2.2%	0	0	0	0	0	0	0	0	0	0	24 2.5%
	Not Hispanic or Latino	292 91.5%	295 92.2%	290 90.1%	0	0	0	0	0	0	0	0	0	0	877 91.3%
	Unknown or Not Reported	17 5.3%	18 5.6%	25 7.8%	0	0	0	0	0	0	0	0	0	0	60 6.2%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	319 participants	320 participants	322 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	961 participants
American Indian or Alaska Native		0	0	1											1
Asian		48	46	49											143
Black or African American		3	6	0											9
Other		8	9	12											29
White		248	239	243											730
Unknown or Not Reported		12	20	17											49
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	319 participants	320 participants	322 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	0 participants	961 participants
Australia		7 2.2%	8 2.5%	11 3.4%	0	0	0	0	0	0	0	0	0	0	26 2.7%
Austria		0 0.0%	2 0.6%	2 0.6%											4 0.4%
Belgium		22 6.9%	10 3.1%	7 2.2%											39 4.1%
Bulgaria		8 2.5%	9 2.8%	4 1.2%											21 2.2%
Canada		7 2.2%	6 1.9%	3 0.9%											16 1.7%
Czech Republic		8 2.5%	9 2.8%	13 4.0%										0	30 3.1%
Denmark		0 0.0%	0 0.0%	2 0.6%											2 0.2%
France		14 4.4%	21 6.6%	19 5.9%											54 5.6%
Germany		19 6.0%	14 4.4%	12 3.7%											45 4.7%
Hungary		11 3.4%	12 3.8%	16 5.0%	0										39 4.1%
Israel		0 0.0%	3 0.9%	3 0.9%	0										6 0.6%
Italy		10 3.1%	11 3.4%	12 3.7%											33 3.4%
Japan		34 10.7%	34 10.6%	39 12.1%											107 11.1%
Netherlands		5 1.6%	8 2.5%	3 0.9%											16 1.7%
New Zealand		4 1.3%	4 1.3%	11 3.4%											19 2.0%
Poland		25 7.8%	26 8.1%	20 6.2%											71 7.4%
Romania		7 2.2%	9 2.8%	8 2.5%											24 2.5%
Russia		26 8.2%	22 6.9%	26 8.1%											74 7.7%
Serbia		1 0.3%	6 1.9%	3 0.9%											10 1.0%
Slovakia		4 1.3%	4 1.3%	2 0.6%											10 1.0%
Ukraine		32 10.0%	26 8.1%	31 9.6%											89 9.3%
United Kingdom		5 1.6%	3 0.9%	13 4.0%											21 2.2%
United States		60 18.8%	63 19.7%	56 17.4%											179 18.6%
Korea		10 3.1%	10 3.1%	6 1.9%											26 2.7%

Outcome Measures

1. Primary Outcome

Title	Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per Global Definition)
Description	As per global definition, clinical remission is defined as a Mayo score less than or equal to (<=)2 points, with no individual subscore greater than (>)1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding [RB], endoscopy findings, and physician's global assessment [PGA]), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant ulcerative colitis (UC) medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

The primary efficacy analysis set (PEAS) consisted of all participants randomized in the induction study.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
	17 5.3%	50 15.6%	50 15.5%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction Study (IS): Placebo Intravenous (IV), IS: Ustekinumab 130 Milligram (mg) IV
	Comments	Statistical Analysis 1
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	10.3
	Confidence Interval	(2-Sided) 95%; 5.7 to 14.9
	Estimation Comments	Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction Study (IS): Placebo Intravenous (IV), IS: Ustekinumab Approximately 6 mg/kg IV
	Comments	Statistical Analysis 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	10.2
	Confidence Interval	(2-Sided) 95%; 5.6 to 14.8
	Estimation Comments	Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.

2. Primary Outcome

Title	Induction Study - Number of Participants With Clinical Remission at Week 8 (As Per US Definition)
Description	As per US definition, clinical remission was defined as absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components pertaining to this outcome measure (OM) (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
	20 6.3%	53 16.6%	61 18.9%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Induction Study (IS): Placebo Intravenous (IV), IS: Ustekinumab 130 Milligram (mg) IV
	Comments	Statistical Analysis 1
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	10.3
	Confidence Interval	(2-Sided) 97.5%; 4.8 to 15.8
	Estimation Comments	Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Induction Study (IS): Placebo Intravenous (IV), IS: Ustekinumab Approximately 6 mg/kg IV
	Comments	Statistical Analysis 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	12.7
	Confidence Interval	(2-Sided) 97.5%; 7.0 to 18.4
	Estimation Comments	Treatment difference between ustekinumab group and placebo group was adjusted with Cochran-Mantel-Haenszel (CMH) weight.

3. Primary Outcome

Title	Maintenance Study: Number of Participants With Clinical Remission at Week 44 (As Per Global Definition)
Description	As per global definition, clinical remission was defined as a Mayo score <=2 points, with no individual subscore >1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in UC medication or an ostomy or colectomy or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of the video of the endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC every 8 weeks (q8w), ustekinumab 90 mg SC every 12 weeks (q12w), or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
	42 24.0%	66 38.4%	77 43.8%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance Study (MS): Placebo Subcutaneous (SC), MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)
	Comments	Statistical Analysis 1
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	14.5
	Confidence Interval	(2-Sided) 95%; 5.5 to 23.6
	Estimation Comments	Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance Study (MS): Placebo Subcutaneous (SC), MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
	Comments	Statistical Analysis 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	19.7
	Confidence Interval	(2-Sided) 95%; 10.3 to 29.0
	Estimation Comments	Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.

4. Primary Outcome

Title	Maintenance Study: Number of Participants With Clinical Remission at Week 44 (as Per US Definition)
Description	Per US definition, clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and a Mayo endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without the physician's global assessment. Absolute stool number is average of daily stool number over the three days. The Mayo rectal bleeding and endoscopy findings subscores were rated as 0 (normal) to 3 (severe). Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC prior to Week 44 and who were missing all 3 of Mayo components pertaining to this OM (absolute stool number, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in clinical remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
	43 24.6%	68 39.5%	75 42.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Maintenance Study (MS): Placebo Subcutaneous (SC), MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)
	Comments	Statistical Analysis 1
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.002
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	15.1
	Confidence Interval	(2-Sided) 95%; 6.0 to 24.2
	Estimation Comments	Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Maintenance Study (MS): Placebo Subcutaneous (SC), MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
	Comments	Statistical Analysis 2
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	< 0.001
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Adjusted treatment difference
	Estimated Value	17.9
	Confidence Interval	(2-Sided) 95%; 8.6 to 27.2
	Estimation Comments	Treatment difference between ustekinumab group and placebo group was adjusted with CMH weight.

5. Secondary Outcome

Title	Induction Study: Number of Participants With Endoscopic Healing at Week 8
Description	Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing endoscopy score at Week 8 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
	44 13.8%	84 26.3%	87 27.0%

6. Secondary Outcome

Title	Induction Study: Number of Participants With Clinical Response at Week 8
Description	Clinical response was defined as a decrease from induction baseline in the Mayo score by >=30 percent (%) and >= 3 points, with either a decrease from baseline in the rectal bleeding subscore >=1 or a rectal bleeding subscore of 0 or 1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score was calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not to be in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
	100 31.3%	164 51.2%	199 61.8%

7. Secondary Outcome

Title	Induction Study - Change From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
Description	The IBDQ is 32-item questionnaire for participants with Inflammatory Bowel Disease (IBD) used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of event onward or participants who had missing IBDQ score at Week 8 had their last value carried forward.
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this outcome measure (OM).

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	317	316	321
Mean (Standard Deviation); Unit of Measure: Units on a scale
	16.1 (31.39)	33.4 (32.53)	35.0 (31.86)

8. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Response up to Week 44
Description	Clinical response: decrease from induction baseline in Mayo score by >= 30% and >= 3 points, with either decrease from induction baseline in rectal bleeding subscore >=1 or rectal bleeding subscore of 0 or 1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5= mild; 6 to 10= moderate; 11 to 12= severe; higher scores indicate worsening of disease. Participants who lost clinical response at any time before Week 44, had prohibited change in UC medication, ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Up to Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
	78 44.6%	117 68.0%	125 71.0%

9. Secondary Outcome

Title	Maintenance Study: Number of Participants With Endoscopic Healing at Week 44
Description	Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It was defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Participants who had prohibited change in UC medication, an ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC prior to Week 44 or who had missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
	50 28.6%	75 43.6%	90 51.1%

10. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per Global Definition)
Description	Per global definition, clinical remission was defined as Mayo score <=2 points, with no individual subscore >1. Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score: sum of 4 subscores and range from 0 to 12, where 3 to 5= mild; 6 to 10= moderate; and 11 to 12= severe; higher scores indicate worsening of disease. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or had all 4 Mayo subscores missing at Week 44 were considered not to have achieved OM of clinical remission and not receiving corticosteroids at Week 44. Participants who had missing value in corticosteroid use at Week 44 had their last value carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS included all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w/ placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
	41 23.4%	65 37.8%	74 42.0%

11. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Remission and Not Receiving Concomitant Corticosteroids (Corticosteroid-free Clinical Remission) at Week 44 (As Per US Definition)
Description	US definition of clinical remission: absolute stool number <=3, rectal bleeding subscore 0 (no blood seen), Mayo endoscopy subscore of 0(normal or inactive disease)/ 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy findings subscores rated: 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or were missing all 3 of Mayo components related to this OM (absolute stool number, rectal bleeding, and Mayo endoscopy subscore) at Week 44 were considered not in corticosteroid-free clinical remission at Week 44. Participants with missing value in corticosteroid use at Week 44 had last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
	42 24.0%	67 39.0%	72 40.9%

12. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Remission up to Week 44 Among Participants Who Achieved Clinical Remission at Maintenance Study Baseline (As Per Global Definition)
Description	Global definition of clinical remission: Mayo score <=2 points, with no individual subscore >1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score: sum of 4 subscores and range from 0 to 12, where 3 to 5= mild; 6 to 10= moderate; and 11 to 12= severe; higher scores indicate worsening of disease. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or had all 4 Mayo subscores missing at Week 44 were considered not to be in clinical remission. Participants who were not in clinical remission at any time points when endoscopic scores were collected before Week 44 were considered not to be in clinical remission up to Week 44. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Up to Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were in clinical remission at maintenance baseline.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	45	40	38
Measure Type: Count of Participants; Unit of Measure: Participants
	17 37.8%	26 65.0%	22 57.9%

13. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Remission up to Week 44 Among Participants Who Achieved Clinical Remission at Maintenance Study Baseline (As Per US Definition)
Description	US definition of clinical remission: absolute stool number <=3, Mayo rectal bleeding subscore of 0 (no blood seen), Mayo endoscopy subscore of 0 (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores: 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsening of UC before Week 44/ missing all 3 of Mayo components (absolute stool number, rectal bleeding, and Mayo endoscopy subscore) at Week 44 were considered not in clinical remission. Participants not in clinical remission at any time point when endoscopic scores collected before Week 44 considered not in clinical remission up to Week 44. Endoscopy subscore assessed during central review of video of endoscopy was used.
Time Frame	Up to Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were in clinical remission at maintenance baseline.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	48	52	44
Measure Type: Count of Participants; Unit of Measure: Participants
	16 33.3%	32 61.5%	27 61.4%

14. Secondary Outcome

Title	Induction Study - Number of Participants With Mucosal Healing at Week 8
Description	Mucosal healing is defined as having both endoscopic healing (EH) and histologic healing (HH). Endoscopic healing: an endoscopy subscore of 0 (normal or inactive disease) or 1 mild disease ([erythema, decreased vascular pattern, mild friability]). Histologic healing: neutrophil infiltration in <5% of crypts, no crypt destruction, and no erosions or ulcerations or granulation tissue. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8 or had missing endoscopy score/ were missing any component of histologic healing (that is assessment of neutrophils in crypts, crypt destruction/ erosions/ ulcerations/ granulations) at Week 8 or who had unevaluable biopsy (that is biopsy collected, but could not be assessed due to sample preparation or technical errors) at Week 8 but who did not achieve endoscopic healing, were considered not to have mucosal healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study, with participants whose mucosal healing status was determined at Week 8.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	316	316	315
Measure Type: Count of Participants; Unit of Measure: Participants
	28 8.9%	64 20.3%	58 18.4%

15. Secondary Outcome

Title	Induction Study - Number of Participants in Clinical Remission With a Rectal Bleeding Subscore of 0 at Week 8 (As Per Global Definition)
Description	As per global definition, clinical remission is defined as Mayo score <=2 points, with no individual subscore >1. The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had missing rectal bleeding subscores at Week 8 were considered not to be in clinical remission with a rectal bleeding subscore of 0. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
	17 5.3%	49 15.3%	49 15.2%

16. Secondary Outcome

Title	Induction Study - Number of Participants in Symptomatic Remission at Week 8
Description	Symptomatic remission was defined as a Mayo stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 and/or both stool frequency and rectal bleeding subscores missing at Week 8 were considered not to be in symptomatic remission.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
	72 22.6%	132 41.3%	144 44.7%

17. Secondary Outcome

Title	Induction Study - Number of Participants in With Normal or Inactive Mucosal Disease at Week 8
Description	Normal or inactive mucosal disease is defined as an endoscopy score of 0. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had a missing endoscopy score at Week 8 were considered not to have normal or inactive mucosal disease. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
	12 3.8%	33 10.3%	25 7.8%

18. Secondary Outcome

Title	Induction Study - Change From Baseline in Mayo Score at Week 8
Description	The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline Mayo score carried forward to Week 8 or who had all 4 Mayo subscores missing at Week 8 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this OM.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	321
Mean (Standard Deviation); Unit of Measure: Units on a scale
	-1.8 (2.40)	-3.2 (2.81)	-3.5 (2.67)

19. Secondary Outcome

Title	Induction Study - Change From Baseline in Partial Mayo Score Through Week 8
Description	The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores; rated as 0 [normal] to 3 [severe]). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants with the partial Mayo score missing at a timepoint had their last available individual partial Mayo subscore carried forward to that timepoint.
Time Frame	Baseline through Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this outcome measure.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	321
Mean (Standard Deviation); Unit of Measure: Units on a scale
Change at Week 2	-1.0 (1.63)	-1.5 (1.74)	-1.6 (1.69)
Change at Week 4	-1.4 (1.86)	-2.1 (1.86)	-2.5 (1.93)
Change at Week 8	-1.5 (2.07)	-2.6 (2.31)	-2.9 (2.20)

20. Secondary Outcome

Title	Induction Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 8
Description	The stool frequency subscore of Mayo score is rated as 0 (normal) to 3 (severe). Stool frequency scores: 0 =normal number of stools, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo stool frequency subscore at the designated analysis timepoint had the last available value for that subscore carried forward.
Time Frame	Up to Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies those participants who were analyzed for this OM.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	321
Measure Type: Count of Participants; Unit of Measure: Participants
Week 2:Normal number of stools	16 5.0%	32 10.0%	26 8.1%
Week 2:1-2 stools more than normal	82 25.7%	99 30.9%	94 29.3%
Week 2: 3-4 stools more than normal	85 26.6%	88 27.5%	90 28.0%
Week 2: 5 or more stools more than normal	136 42.6%	101 31.6%	111 34.6%
Week 4:Normal number of stools	30 9.4%	36 11.3%	50 15.6%
Week 4:1-2 stools more than normal	85 26.6%	122 38.1%	126 39.3%
Week 4: 3-4 stools more than normal	81 25.4%	78 24.4%	72 22.4%
Week 4: 5 or more stools more than normal	123 38.6%	84 26.3%	73 22.7%
Week 8:Normal number of stools	28 8.8%	66 20.6%	71 22.1%
Week 8:1-2 stools more than normal	93 29.2%	112 35.0%	110 34.3%
Week 8: 3-4 stools more than normal	76 23.8%	61 19.1%	85 26.5%
Week 8: 5 or more stools more than normal	122 38.2%	81 25.3%	55 17.1%

21. Secondary Outcome

Title	Induction Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 8
Description	The rectal bleeding subscore of the Mayo Score is rated as 0 (normal) to 3 (severe). Rectal bleeding scores: 0 = no blood seen, 1 = streaks of blood with stool less than half the time, 2 = obvious blood with stool most of the time, and 3 = blood alone passed. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo rectal bleeding subscore at the designated analysis timepoint had the last available value for that subscore carried forward.
Time Frame	Up to Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
Week 2: No blood seen	83 26.0%	104 32.5%	120 37.3%
Week 2:Streaks of blood with stool < half time	119 37.3%	122 38.1%	131 40.7%
Week 2: Obvious blood with stool most of the time	94 29.5%	83 25.9%	63 19.6%
Week 2: Blood alone passed	23 7.2%	11 3.4%	8 2.5%
Week 4:No blood seen	117 36.7%	138 43.1%	161 50.0%
Week 4:Streaks of blood with stool < half time	103 32.3%	117 36.6%	115 35.7%
Week 4: Obvious blood with stool most of time	75 23.5%	54 16.9%	40 12.4%
Week 4: Blood alone passed	24 7.5%	11 3.4%	6 1.9%
Week 8:No blood seen	119 37.3%	173 54.1%	204 63.4%
Week 8:Streaks of blood with stool < half the time	106 33.2%	85 26.6%	81 25.2%
Week 8: Obvious blood with stool most of the time	73 22.9%	54 16.9%	31 9.6%
Week 8: Blood alone passed	21 6.6%	8 2.5%	6 1.9%

22. Secondary Outcome

Title	Induction Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 8
Description	The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0 = normal or inactive disease, 1 = mild disease (erythema, decreased vascular pattern, mild friability), 2 = moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 = Severe disease (spontaneous bleeding, ulceration). Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo endoscopy subscore at Week 8 had the last available value for that subscore carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
Week 8: Normal or inactive disease	12 3.8%	33 10.3%	25 7.8%
Week 8:Mild disease	32 10.0%	51 15.9%	62 19.3%
Week 8: Moderate disease	99 31.0%	96 30.0%	84 26.1%
Week 8: Severe disease	176 55.2%	140 43.8%	151 46.9%

23. Secondary Outcome

Title	Induction Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 8
Description	The physician's global assessment subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Physician's global assessment scores: 0 = normal, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing Mayo physician's global assessment subscore at the designated analysis timepoint had the last available value for that subscore carried forward.
Time Frame	Up to Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
Week 2: Normal	3 0.9%	4 1.3%	10 3.1%
Week 2:Mild disease	66 20.7%	82 25.6%	81 25.2%
Week 2: Moderate disease	194 60.8%	193 60.3%	181 56.2%
Week 2: Severe disease	56 17.6%	41 12.8%	50 15.5%
Week 4:Normal	13 4.1%	14 4.4%	22 6.8%
Week 4:Mild disease	82 25.7%	118 36.9%	137 42.5%
Week 4: Moderate disease	181 56.7%	164 51.2%	138 42.9%
Week 4: Severe disease	43 13.5%	24 7.5%	25 7.8%
Week 8:Normal	21 6.6%	37 11.6%	49 15.2%
Week 8:Mild disease	83 26.0%	136 42.5%	135 41.9%
Week 8: Moderate disease	153 48.0%	115 35.9%	106 32.9%
Week 8: Severe disease	62 19.4%	32 10.0%	32 9.9%

24. Secondary Outcome

Title	Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per Global Definition)
Description	Global definition of clinical remission: Mayo score<=2 points, with no individual subscore >1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score = sum of 4 subscores and range from 0 to 12, where 3 to 5 = mild; 6 to 10 = moderate; 11 to 12 = severe; higher scores indicate worsening of disease. BF: participants received treatment with 1 or more tumor necrosis factor (TNF) antagonists and/or vedolizumab at dose approved for treatment of UC and did not respond initially or responded initially but lost response or were intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/colectomy before Week 8 or who had all 4 Mayo subscores missing at Week 8 considered not in clinical remission. Endoscopy subscore assessed during central review of video of endoscopy was used.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

The primary efficacy analysis set consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

Arm/Group Title		Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:		Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed		319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with BF	Number Analyzed	161 participants	164 participants	166 participants
		2 1.2%	19 11.6%	21 12.7%
Participants without BF	Number Analyzed	158 participants	156 participants	156 participants
		15 9.5%	31 19.9%	29 18.6%

25. Secondary Outcome

Title	Induction Study - Number of Participants With Clinical Remission at Week 8 by Biologic Failure (BF) Status (As Per US Definition)
Description	US definition of clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), Mayo endoscopy subscore of (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without PGA. Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores rated 0 (normal) to 3 (severe). BF: participants received treatment with 1/ more TNF antagonists/ vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8/ missing all 3 of Mayo components (absolute stool number, rectal bleeding, Mayo endoscopy subscore) at Week 8 considered not in clinical remission. Endoscopy subscore assessed during central review used endoscopy video.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

Arm/Group Title		Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:		Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed		319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with BF	Number Analyzed	161 participants	164 participants	166 participants
		4 2.5%	19 11.6%	22 13.3%
Participants without BF	Number Analyzed	158 participants	156 participants	156 participants
		16 10.1%	34 21.8%	39 25.0%

26. Secondary Outcome

Title	Induction Study - Number of Participants With Endoscopic Healing at Week 8 by Biologic Failure Status
Description	Number of participants with endoscopic healing at week 8 by BF status were reported. Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). BF: Participants received treatment with 1/ more TNF antagonists and/or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response/ were intolerant of medication. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 or who had a missing endoscopy score at Week 8 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

Arm/Group Title		Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:		Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed		319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with BF	Number Analyzed	161 participants	164 participants	166 participants
		11 6.8%	30 18.3%	35 21.1%
Participants without BF	Number Analyzed	158 participants	156 participants	156 participants
		33 20.9%	54 34.6%	52 33.3%

27. Secondary Outcome

Title	Induction Study - Number of Participants With Clinical Response at Week 8 by Biologic Failure Status
Description	Clinical response: decrease from induction baseline in Mayo score by >=30% and >= 3 points, with either decrease from baseline in rectal bleeding subscore >=1/ rectal bleeding subscore= 0/1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score =sum of 4 subscores and range from 0 to 12, where 3 to 5 = mild; 6 to 10 = moderate; 11 to 12 = severe; higher scores =worsening of disease. BF: participants received treatment with 1/ more TNF antagonists and/or vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ were intolerant of medication. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy before Week 8 or who had all 4 Mayo subscores missing at Week 8 were considered not in clinical response. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

Arm/Group Title		Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:		Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed		319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with BF	Number Analyzed	161 participants	164 participants	166 participants
		44 27.3%	74 45.1%	95 57.2%
Participants without BF	Number Analyzed	158 participants	156 participants	156 participants
		56 35.4%	90 57.7%	104 66.7%

28. Secondary Outcome

Title	Induction Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)
Description	Number of participants in remission based on stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 8 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
	25 7.8%	60 18.8%	67 20.8%

29. Secondary Outcome

Title	Induction Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 8 (US Specific)
Description	Number of participants in remission based on stool frequency subscore of 0 (normal number of stools), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 8 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who were missing all 3 of the Mayo components related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 8 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
	10 3.1%	35 10.9%	29 9.0%

30. Secondary Outcome

Title	Induction Study - Change From Baseline in C-reactive Protein (CRP) Concentration Through Week 8
Description	Change from baseline in CRP concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing CRP value at the designated analysis timepoint had their last value carried forward.
Time Frame	Baseline through Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	316	315	320
Median (Inter-Quartile Range); Unit of Measure: milligram per liter (mg/L)
Change at Week 2	-0.01; (-2.79 to 1.21)	-0.75; (-4.53 to 0.00)	-0.92; (-6.24 to 0.05)
Change at Week 4	-0.18; (-3.12 to 0.71)	-1.08; (-5.86 to 0.00)	-1.94; (-7.16 to -0.06)
Change at Week 8	0.00; (-2.47 to 2.61)	-1.30; (-5.04 to 0.30)	-1.43; (-7.63 to 0.00)

31. Secondary Outcome

Title	Induction Study - Number of Participants With Normalized CRP (<=3 mg/L) up to Week 8 Among Participants With Abnormal CRP (>3 mg/L) at Baseline
Description	Number of participants with normalized CRP (<=3 mg/L) up to Week 8 among participants with abnormal CRP (>3 mg/L) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing CRP value at the designated analysis timepoint were considered not to have normalized CRP.
Time Frame	Up to Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study, with those participants who were having abnormal CRP at baseline.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	185	185	199
Measure Type: Count of Participants; Unit of Measure: Participants
Week 2	36 19.5%	54 29.2%	58 29.1%
Week 4	41 22.2%	70 37.8%	75 37.7%
Week 8	39 21.1%	63 34.1%	77 38.7%

32. Secondary Outcome

Title	Induction Study - Change From Baseline in Fecal Lactoferrin Concentration Through Week 8
Description	Change from baseline in fecal lactoferrin concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward.
Time Frame	Baseline through Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	294	302	306
Median (Inter-Quartile Range); Unit of Measure: microgram per gram (mcg/g)
Change at Week 2	0.00; (-103.22 to 120.67)	-4.67; (-140.04 to 75.46)	-24.06; (-202.88 to 60.23)
Change at Week 4	0.00; (-117.67 to 133.67)	-29.26; (-203.79 to 46.29)	-69.51; (-240.62 to 24.90)
Change at Week 8	-4.71; (-149.28 to 92.90)	-43.41; (-220.99 to 29.10)	-101.46; (-301.23 to 0.00)

33. Secondary Outcome

Title	Induction Study - Number of Participants With Normalized Fecal Lactoferrin (<=7.24 mcg/g) up to Week 8 Among Participants With Abnormal Fecal Lactoferrin (>7.24 mcg/g) at Baseline
Description	Number of participants with normalized fecal lactoferrin (<=7.24 mcg/g) up to Week 8 among participants with abnormal fecal lactoferrin (> 7.24 mcg/g) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing fecal lactoferrin value at the designated analysis timepoint were considered not to have normalized fecal lactoferrin.
Time Frame	Up to Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study, with those participants who had abnormal fecal lactoferrin at baseline.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	280	291	294
Measure Type: Count of Participants; Unit of Measure: Participants
Week 2	16 5.7%	17 5.8%	15 5.1%
Week 4	16 5.7%	37 12.7%	33 11.2%
Week 8	26 9.3%	50 17.2%	43 14.6%

34. Secondary Outcome

Title	Induction Study - Change From Baseline in Fecal Calprotectin Concentration Through Week 8
Description	Change from baseline in fecal calprotectin concentration through Week 8 was reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from the time of the event onward. Participants who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward.
Time Frame	Baseline through Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	289	296	300
Median (Inter-Quartile Range); Unit of Measure: milligram per kilogram (mg/kg)
Change at Week 2	0.00; (-702.00 to 631.00)	-29.00; (-933.50 to 492.00)	-127.00; (-1029.50 to 433.50)
Change at Week 4	-2.00; (-961.00 to 894.00)	-223.00; (-1200.50 to 266.50)	-485.50; (-1536.50 to 158.50)
Change at Week 8	-59.00; (-996.00 to 751.00)	-431.50; (-1635.50 to 175.00)	-715.50; (-1913.50 to 0.00)

35. Secondary Outcome

Title	Induction Study - Number of Participants With Normalized Fecal Calprotectin (<=250 mg/kg) up to Week 8 Among Participants With Abnormal Fecal Calprotectin (>250 mg/kg) at Baseline
Description	Number of participants with normalized fecal calprotectin (<=250 milligram per kilogram [mg/kg) up to Week 8 among participants with abnormal fecal calprotectin (>250 mg/kg) at baseline were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing fecal calprotectin value at the designated analysis timepoint were considered not to have normalized fecal calprotectin.
Time Frame	Up to Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all randomized participants in the induction study, with abnormal fecal calprotectin (>250 mg/kg) at baseline.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	250	264	274
Measure Type: Count of Participants; Unit of Measure: Participants
Week 2	20 8.0%	37 14.0%	37 13.5%
Week 4	25 10.0%	45 17.0%	47 17.2%
Week 8	51 20.4%	64 24.2%	70 25.5%

36. Secondary Outcome

Title	Induction Study - Number of Participants With a >20-point Improvement From Baseline in Total Inflammatory Bowel Disease Questionnaire (IBDQ) Score at Week 8
Description	The IBDQ is 32-item questionnaire for participants with Inflammatory Bowel Disease (IBD) used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy prior to the Week 8 or who had a missing IBDQ score at either baseline or Week 8 were considered not to have achieved a greater than 20-point improvement.
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	320	322
Measure Type: Count of Participants; Unit of Measure: Participants
	118 37.0%	196 61.3%	200 62.1%

37. Secondary Outcome

Title	Induction Study - Change From Baseline in IBDQ Dimension Scores at Week 8
Description	The IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward and participants who had missing IBDQ dimension score at designated analysis timepoint had their last value carried forward.
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified category.

Arm/Group Title		Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:		Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed		319	320	322
Mean (Standard Deviation); Unit of Measure: Units on a scale
Bowel: Change at Week 8	Number Analyzed	317 participants	319 participants	321 participants
		5.9 (10.34)	12.5 (11.27)	12.7 (11.11)
Emotional: Change at Week 8	Number Analyzed	317 participants	317 participants	321 participants
		5.3 (12.33)	10.1 (12.39)	11.2 (12.33)
Systemic: Change at Week 8	Number Analyzed	317 participants	319 participants	321 participants
		2.3 (5.59)	5.1 (5.59)	5.2 (5.65)
Social: Change at Week 8	Number Analyzed	317 participants	318 participants	321 participants
		2.7 (6.55)	5.7 (7.41)	5.9 (6.44)

38. Secondary Outcome

Title	Induction Study - Change From Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Week 8
Description	SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, physical component summary (PCS: calculated from subscales physical functioning, role-physical, bodily pain, and general health) and mental component summary (MCS: calculated from subscales vitality, social functioning, role-emotional and mental health) scores were derived. Summary MCS and PCS score is also scaled from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing component summary score at Week 8 had their last value carried forward.
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

Arm/Group Title		Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:		Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed		319	320	322
Mean (Standard Deviation); Unit of Measure: Units on a scale
PCS: Change at Week 8	Number Analyzed	319 participants	318 participants	322 participants
		2.1 (6.39)	4.7 (6.49)	5.2 (6.16)
MCS: Change at Week 8	Number Analyzed	319 participants	318 participants	322 participants
		2.2 (10.20)	5.3 (9.63)	5.1 (9.72)

39. Secondary Outcome

Title	Induction Study - Change From Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Week 8
Description	SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing individual scale at a designated analysis timepoint had their last value carried forward.
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants who were analyzed for this OM.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	319	318	322
Mean (Standard Deviation); Unit of Measure: Units on a scale
Physical functioning: Change at Week 8	1.7 (6.46)	3.0 (6.46)	3.4 (6.51)
Role-physical: Change at Week 8	2.4 (9.51)	5.9 (9.34)	6.1 (8.53)
Bodily pain: Change at Week 8	2.6 (9.71)	6.0 (9.45)	6.8 (9.08)
General health: Change at Week 8	1.5 (7.36)	4.7 (7.74)	4.5 (7.10)
Vitality: Change at Week 8	2.7 (9.93)	6.1 (9.35)	6.8 (9.78)
Social functioning: Change at Week 8	3.0 (10.52)	6.6 (10.25)	6.4 (9.84)
Role-emotional: Change at Week 8	1.6 (11.04)	4.4 (11.04)	3.6 (10.53)
Mental health: Change at Week 8	2.0 (9.86)	4.7 (9.14)	5.1 (9.27)

40. Secondary Outcome

Title	Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Week 8
Description	EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward.
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants analyzed for this OM.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	317	319	322
Mean (Standard Deviation); Unit of Measure: Units on a scale
	0.04 (0.182)	0.09 (0.182)	0.11 (0.172)

41. Secondary Outcome

Title	Induction Study - Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Health State Visual Analog Scale (VAS) Score at Week 8
Description	The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant. Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward.
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, N (number of participants analyzed) signifies participants analyzed for this OM.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed	317	319	322
Mean (Standard Deviation); Unit of Measure: Units on a scale
	5.71 (19.584)	13.64 (20.394)	13.51 (18.447)

42. Secondary Outcome

Title	Induction Study - Percentage of Participants With Change From Baseline in EuroQOL-5 Dimensions (EQ-5D) Score at Week 8
Description	EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication or an ostomy or colectomy prior to Week 8 had their baseline value carried forward from time of event onward or participants who had missing score at a designated analysis timepoint had their last value carried forward. Percentage of participants with various responses to the 5 dimensions were reported.
Time Frame	Baseline and Week 8

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants randomized in the induction study. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified category.

Arm/Group Title		Induction Study (IS): Placebo Intravenous (IV)	IS: Ustekinumab 130 Milligram (mg) IV	IS: Ustekinumab Approximately 6 mg/kg IV
Arm/Group Description:		Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.
Overall Number of Participants Analyzed		319	320	322
Measure Type: Number; Unit of Measure: Percentage of Participants
Mobility:Improved at Week 8	Number Analyzed	317 participants	319 participants	322 participants
		18.0	16.3	24.2
Mobility:No change at Week 8	Number Analyzed	317 participants	319 participants	322 participants
		71.9	71.8	66.8
Mobility:Worsened at Week 8	Number Analyzed	317 participants	319 participants	322 participants
		10.1	11.9	9.0
Self-care:Improved at Week 8	Number Analyzed	317 participants	319 participants	322 participants
		5.4	6.9	7.5
Self-care:No change at Week 8	Number Analyzed	317 participants	319 participants	322 participants
		89.6	88.4	90.4
Self-care:Worsened at Week 8	Number Analyzed	317 participants	319 participants	322 participants
		5.0	4.7	2.2
Usual activities:Improved at Week 8	Number Analyzed	317 participants	319 participants	322 participants
		34.1	49.5	45.0
Usual activities:No Change at Week 8	Number Analyzed	317 participants	319 participants	322 participants
		51.1	40.4	44.1
Usual activities:Worsened at Week 8	Number Analyzed	317 participants	319 participants	322 participants
		14.8	10.0	10.9
Pain/discomfort: Improved at Week 8	Number Analyzed	319 participants	320 participants	322 participants
		34.4	44.2	43.5
Pain/discomfort: No Change at Week 8	Number Analyzed	317 participants	319 participants	322 participants
		49.8	48.3	48.1
Pain/discomfort: Worsened at Week 8	Number Analyzed	317 participants	319 participants	322 participants
		15.8	7.5	8.4
Anxiety/depression: Improved at Week 8	Number Analyzed	317 participants	319 participants	322 participants
		26.8	33.5	37.6
Anxiety/depression: No Change at Week 8	Number Analyzed	317 participants	319 participants	322 participants
		55.5	54.2	51.6
Anxiety/depression: Worsened at Week 8	Number Analyzed	317 participants	319 participants	322 participants
		17.7	12.2	10.9

43. Secondary Outcome

Title	Maintenance Study - Change From Maintenance Baseline in Mayo Score at Week 44
Description	The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy , or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to Week 44 had their Week 0 value of the induction study carried forward or who had all 4 Mayo subscores missing at Week 44 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Baseline and Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Mean (Standard Deviation); Unit of Measure: Units on a scale
	1.6 (3.45)	0.1 (3.02)	-0.5 (2.88)

44. Secondary Outcome

Title	Maintenance Study - Change From Induction Baseline in Mayo Score at Week 44
Description	The Mayo score consists of 4 subscores (stool frequency, rectal bleeding, endoscopy findings, and physician's global assessment), rated as 0 (normal) to 3 (severe). Total Mayo score is calculated as the sum of 4 subscores and values range from 0 to 12 scores, where 3 to 5 = mild; 6 to 10 = moderate; and 11 to 12 = severe; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward or who had all 4 Mayo subscores missing at Week 44 had their last available individual Mayo subscores carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Induction Baseline and Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Mean (Standard Deviation); Unit of Measure: Units on a scale
	-3.3 (3.34)	-5.0 (3.27)	-5.6 (3.17)

45. Secondary Outcome

Title	Maintenance Study - Number of Participants With Individual Mayo Subscore (Stool Frequency) up to Week 44
Description	Stool frequency subscore of Mayo score is rated as 0 (normal) to 3 (severe). Stool frequency scores: 0 =normal number of stools, 1 = 1-2 stools more than normal, 2 = 3-4 stools more than normal, 3 = 5 or more stools more than normal. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward or who had a missing Mayo subscores at a timepoint had the last available value for that subscore carried forward.
Time Frame	Up to Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
Week 4:Normal number of stools	56 32.0%	61 35.5%	58 33.0%
Week 4:1-2 stools more than normal	91 52.0%	76 44.2%	86 48.9%
Week 4: 3-4 stools more than normal	21 12.0%	26 15.1%	29 16.5%
Week 4: 5 or more stools more than normal	7 4.0%	9 5.2%	3 1.7%
Week 8:Normal number of stools	70 40.0%	62 36.0%	61 34.7%
Week 8:1-2 stools more than normal	69 39.4%	75 43.6%	84 47.7%
Week 8: 3-4 stools more than normal	22 12.6%	25 14.5%	26 14.8%
Week 8: 5 or more stools more than normal	14 8.0%	10 5.8%	5 2.8%
Week 12:Normal number of stools	62 35.4%	55 32.0%	64 36.4%
Week 12:1-2 stools more than normal	72 41.1%	75 43.6%	85 48.3%
Week 12: 3-4 stools more than normal	20 11.4%	28 16.3%	21 11.9%
Week 12: 5 or more stools more than normal	21 12.0%	14 8.1%	6 3.4%
Week 16:Normal number of stools	63 36.0%	51 29.7%	73 41.5%
Week 16:1-2 stools more than normal	66 37.7%	78 45.3%	77 43.8%
Week 16: 3-4 stools more than normal	25 14.3%	27 15.7%	15 8.5%
Week 16: 5 or more stools more than normal	21 12.0%	16 9.3%	11 6.3%
Week 20:Normal number of stools	59 33.7%	63 36.6%	67 38.1%
Week 20:1-2 stools more than normal	55 31.4%	65 37.8%	85 48.3%
Week 20: 3-4 stools more than normal	34 19.4%	26 15.1%	15 8.5%
Week 20: 5 or more stools more than normal	27 15.4%	18 10.5%	9 5.1%
Week 24:Normal number of stools	50 28.6%	64 37.2%	72 40.9%
Week 24:1-2 stools more than normal	63 36.0%	61 35.5%	73 41.5%
Week 24: 3-4 stools more than normal	31 17.7%	31 18.0%	20 11.4%
Week 24: 5 or more stools more than normal	31 17.7%	16 9.3%	11 6.3%
Week 28:Normal number of stools	52 29.7%	64 37.2%	67 38.1%
Week 28:1-2 stools more than normal	53 30.3%	64 37.2%	76 43.2%
Week 28: 3-4 stools more than normal	34 19.4%	24 14.0%	22 12.5%
Week 28: 5 or more stools more than normal	36 20.6%	20 11.6%	11 6.3%
Week 32:Normal number of stools	51 29.1%	59 34.3%	72 40.9%
Week 32:1-2 stools more than normal	55 31.4%	66 38.4%	73 41.5%
Week 32: 3-4 stools more than normal	35 20.0%	25 14.5%	18 10.2%
Week 32: 5 or more stools more than normal	34 19.4%	22 12.8%	13 7.4%
Week 36:Normal number of stools	49 28.0%	59 34.3%	77 43.8%
Week 36:1-2 stools more than normal	52 29.7%	60 34.9%	66 37.5%
Week 36: 3-4 stools more than normal	36 20.6%	29 16.9%	18 10.2%
Week 36: 5 or more stools more than normal	38 21.7%	24 14.0%	15 8.5%
Week 40:Normal number of stools	49 28.0%	55 32.0%	81 46.0%
Week 40:1-2 stools more than normal	50 28.6%	65 37.8%	58 33.0%
Week 40: 3-4 stools more than normal	36 20.6%	26 15.1%	21 11.9%
Week 40: 5 or more stools more than normal	40 22.9%	26 15.1%	16 9.1%
Week 44:Normal number of stools	46 26.3%	62 36.0%	71 40.3%
Week 44:1-2 stools more than normal	53 30.3%	57 33.1%	72 40.9%
Week 44: 3-4 stools more than normal	35 20.0%	28 16.3%	16 9.1%
Week 44: 5 or more stools more than normal	41 23.4%	25 14.5%	17 9.7%

46. Secondary Outcome

Title	Maintenance Study - Number of Participants With Individual Mayo Subscore (Rectal Bleeding) up to Week 44
Description	The rectal bleeding subscore of the Mayo Score is rated as 0 (normal) to 3 (severe). Rectal bleeding scores: 0 = no blood seen, 1 = streaks of blood with stool <half time, 2 = obvious blood with stool most of time, and 3 = blood alone passed. Higher scores = worsening of disease. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC before Week 44 had their Week 0 value of induction study carried forward from time of event onward and who had missing Mayo subscores at timepoint had last available value for that subscore carried forward.
Time Frame	Up to Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
Week 4:No blood seen	149 85.1%	148 86.0%	143 81.3%
Week 4:Streaks of blood with stool < half time	20 11.4%	23 13.4%	29 16.5%
Week 4: Obvious blood with stool most of the time	4 2.3%	1 0.6%	24 13.6%
Week 4: Blood alone passed	2 1.1%	0 0.0%	0 0.0%
Week 8:No blood seen	139 79.4%	151 87.8%	141 80.1%
Week 8:Streaks of blood with stool < half time	27 15.4%	17 9.9%	31 17.6%
Week 8: Obvious blood with stool most of time	6 3.4%	3 1.7%	4 2.3%
Week 8:Blood alone passed	3 1.7%	1 0.6%	0 0.0%
Week 12:No blood seen	141 80.6%	144 83.7%	149 84.7%
Week 12:Streaks of blood with stool <half time	21 12.0%	19 11.0%	18 10.2%
Week 12: Obvious blood with stool most of the time	10 5.7%	8 4.7%	6 3.4%
Week 12: Blood alone passed	3 1.7%	1 0.6%	3 1.7%
Week 16:No blood seen	134 76.6%	145 84.3%	150 85.2%
Week 16:Streaks of blood with stool < half time	24 13.7%	17 9.9%	17 9.7%
Week 16: Obvious blood with stool most of the time	13 7.4%	8 4.7%	8 4.5%
Week 16: Blood alone passed	4 2.3%	2 1.2%	1 0.6%
Week 20:No blood seen	120 68.6%	141 82.0%	144 81.8%
Week 20:Streaks of blood with stool <half time	31 17.7%	17 9.9%	20 11.4%
Week 20: Obvious blood with stool most of the time	19 10.9%	12 7.0%	11 6.3%
Week 20: Blood alone passed	5 2.9%	2 1.2%	1 0.6%
Week 24:No blood seen	114 65.1%	139 80.8%	144 81.8%
Week 24:Streaks of blood with stool <half time	32 18.3%	18 10.5%	19 10.8%
Week 24: Obvious blood with stool most of the time	23 13.1%	12 7.0%	11 6.3%
Week 24: Blood alone passed	6 3.4%	3 1.7%	2 1.1%
Week 28:No blood seen	114 65.1%	141 82.0%	147 83.5%
Week 28:Streaks of blood with stool <half time	26 14.9%	18 10.5%	12 6.8%
Week 28: Obvious blood with stool most of the time	28 16.0%	10 5.8%	14 8.0%
Week 28: Blood alone passed	7 4.0%	3 1.7%	3 1.7%
Week 32:No blood seen	109 62.3%	138 80.2%	147 83.5%
Week 32:Streaks of blood with stool <half time	32 18.3%	16 9.3%	13 7.4%
Week 32: Obvious blood with stool most of the time	25 14.3%	14 8.1%	14 8.0%
Week 32: Blood alone passed	9 5.1%	4 2.3%	2 1.1%
Week 36:No blood seen	108 61.7%	136 79.1%	150 85.2%
Week 36:Streaks of blood with stool <half time	30 17.1%	18 10.5%	9 5.1%
Week 36: Obvious blood with stool most of the time	28 16.0%	15 8.7%	15 8.5%
Week 36: Blood alone passed	9 5.1%	3 1.7%	2 1.1%
Week 40:No blood seen	105 60.0%	132 76.7%	147 83.5%
Week 40:Streaks of blood with stool <half time	33 18.9%	22 12.8%	10 5.7%
Week 40: Obvious blood with stool most of the time	28 16.0%	13 7.6%	17 9.7%
Week 40: Blood alone passed	9 5.1%	5 2.9%	2 1.1%
Week 44:No blood seen	101 57.7%	137 79.7%	139 79.0%
Week 44::Streaks of blood with stool <half time	35 20.0%	15 8.7%	16 9.1%
Week 44: Obvious blood with stool most of the time	30 17.1%	15 8.7%	19 10.8%
Week 44: Blood alone passed	9 5.1%	5 2.9%	2 1.1%

47. Secondary Outcome

Title	Maintenance Study - Number of Participants With Individual Mayo Subscore (Endoscopy Findings) at Week 44
Description	The endoscopy findings subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Endoscopy finding scores: 0 =normal/ inactive disease, 1 =mild disease (erythema, decreased vascular pattern, mild friability), 2 =moderate disease (marked erythema, absent vascular pattern, friability, erosions), and 3 =severe disease (spontaneous bleeding, ulceration). Higher scores = worsening of disease. Participants who had prohibited change in concomitant UC medication/ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 had Week 0 value of induction study carried forward from time of event onward and who had missing endoscopy subscores at timepoint had last available value for that subscore carried forward. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
Week 44: Normal or inactive disease	33 18.9%	43 25.0%	52 29.5%
Week 44:Mild disease	21 12.0%	37 21.5%	42 23.9%
Week 44: Moderate disease	40 22.9%	42 24.4%	50 28.4%
Week 44: Severe disease	81 46.3%	50 29.1%	32 18.2%

48. Secondary Outcome

Title	Maintenance Study - Number of Participants With Individual Mayo Subscore (Physician's Global Assessment) up to Week 44
Description	The physician's global assessment subscore of the Mayo score is rated as 0 (normal) to 3 (severe). Physician's global assessment scores: 0 = normal, 1 = mild disease, 2 = moderate disease, and 3 = severe disease. Higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and who had a missing Mayo subscores at a timepoint had the last available value for that subscore carried forward.
Time Frame	Up to Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Induction Study (IS): Placebo Intravenous (IV)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
Week 4:Normal	62 35.4%	61 35.5%	59 33.5%
Week 4:Mild disease	100 57.1%	99 57.6%	105 59.7%
Week 4: Moderate disease	12 6.9%	12 7.0%	11 6.3%
Week 4: Severe disease	1 0.6%	0 0.0%	1 0.6%
Week 8:Normal	65 37.1%	70 40.7%	76 43.2%
Week 8:Mild disease	90 51.4%	89 51.7%	88 50.0%
Week 8: Moderate disease	17 9.7%	13 7.6%	11 6.3%
Week 8:Severe disease	3 1.7%	0 0.0%	1 0.6%
Week 12:Normal	66 37.7%	68 39.5%	73 41.5%
Week 12:Mild disease	79 45.1%	81 47.1%	88 50.0%
Week 12: Moderate disease	26 14.9%	16 9.3%	14 8.0%
Week 12: Severe disease	4 2.3%	7 4.1%	1 0.6%
Week 16:Normal	67 38.3%	82 47.7%	83 47.2%
Week 16:Mild disease	68 38.9%	69 40.1%	78 44.3%
Week 16: Moderate disease	32 18.3%	14 8.1%	13 7.4%
Week 16: Severe disease	8 4.6%	7 4.1%	2 1.1%
Week 20:Normal	65 37.1%	85 49.4%	84 47.7%
Week 20:Mild disease	57 32.6%	63 36.6%	73 41.5%
Week 20: Moderate disease	41 23.4%	16 9.3%	16 9.1%
Week 20: Severe disease	12 6.9%	8 4.7%	3 1.7%
Week 24:Normal	54 30.9%	84 48.8%	91 51.7%
Week 24:Mild disease	61 34.9%	65 37.8%	68 38.6%
Week 24: Moderate disease	44 25.1%	14 8.1%	15 8.5%
Week 24: Severe disease	16 9.1%	9 5.2%	2 1.1%
Week 28:Normal	58 33.1%	86 50.0%	89 50.6%
Week 28:Mild disease	52 29.7%	63 36.6%	65 36.9%
Week 28: Moderate disease	47 26.9%	14 8.1%	20 11.4%
Week 28: Severe disease	18 10.3%	9 5.2%	2 1.1%
Week 32:Normal	55 31.4%	84 48.8%	92 52.3%
Week 32:Mild disease	52 29.7%	56 32.6%	62 35.2%
Week 32: Moderate disease	46 26.3%	23 13.4%	19 10.8%
Week 32: Severe disease	22 12.6%	9 5.2%	3 1.7%
Week 36: Normal	59 33.7%	78 45.3%	93 52.8%
Week 36:Mild disease	45 25.7%	60 34.9%	60 34.1%
Week 36: Moderate disease	47 26.9%	24 14.0%	19 10.8%
Week 36: Severe disease	24 13.7%	10 5.8%	4 2.3%
Week 40:Normal	57 32.6%	83 48.3%	91 51.7%
Week 40:Mild disease	48 27.4%	50 29.1%	60 34.1%
Week 40: Moderate disease	44 25.1%	24 14.0%	21 11.9%
Week 40: Severe disease	26 14.9%	15 8.7%	4 2.3%
Week 44:Normal	47 26.9%	78 45.3%	85 48.3%
Week 44:Mild disease	44 25.1%	54 31.4%	62 35.2%
Week 44:Moderate disease	57 32.6%	24 14.0%	25 14.2%
Week 44: Severe disease	27 15.4%	16 9.3%	4 2.3%

49. Secondary Outcome

Title	Maintenance Study - Change From Maintenance Baseline in Partial Mayo Score Through Week 44
Description	The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores), rated as 0 (normal) to 3 (severe). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point.
Time Frame	Baseline through Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Mean (Standard Deviation); Unit of Measure: Units on a scale
Change at Week 4	-0.2 (1.24)	-0.3 (1.23)	-0.1 (1.26)
Change at Week 8	-0.1 (1.59)	-0.3 (1.15)	-0.2 (1.44)
Change at Week 12	0.1 (1.82)	0.0 (1.66)	-0.2 (1.63)
Change at Week 16	0.3 (2.07)	-0.1 (1.76)	-0.3 (1.76)
Change at Week 20	0.6 (2.36)	-0.1 (1.91)	-0.2 (1.92)
Change at Week 24	0.9 (2.34)	0.0 (2.02)	-0.3 (1.88)
Change at Week 28	1.0 (2.53)	-0.1 (1.95)	-0.2 (1.94)
Change at Week 32	1.1 (2.60)	0.1 (2.12)	-0.2 (1.96)
Change at Week 36	1.2 (2.62)	0.2 (2.13)	-0.2 (2.08)
Change at Week 40	1.3 (2.64)	0.3 (2.27)	-0.2 (1.97)
Change at Week 44	1.5 (2.63)	0.3 (2.29)	0.0 (2.09)

50. Secondary Outcome

Title	Maintenance Study - Change From Induction Baseline in Partial Mayo Score Through Week 44
Description	The partial Mayo score, which is sum of 3 subscores of the Mayo score without the endoscopy subscore (stool frequency, rectal bleeding, and physician's global assessment subscores; rated as 0 [normal] to 3 [severe]). The partial Mayo score is calculated as the sum of the 3 subscores and values range from 0 to 9; higher scores indicate worsening of the disease. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing partial Mayo score at a time point had their last available individual partial Mayo subscore carried forward to that time point.
Time Frame	Baseline through Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Mean (Standard Deviation); Unit of Measure: Units on a scale
Change at Week 4	-4.2 (1.70)	-4.5 (1.76)	-4.4 (1.72)
Change at Week 8	-4.1 (1.80)	-4.5 (1.68)	-4.5 (1.85)
Change at Week 12	-3.9 (2.07)	-4.2 (2.02)	-4.5 (2.02)
Change at Week 16	-3.7 (2.17)	-4.3 (2.07)	-4.6 (2.08)
Change at Week 20	-3.4 (2.26)	-4.3 (2.13)	-4.5 (2.13)
Change at Week 24	-3.1 (2.36)	-4.2 (2.26)	-4.5 (2.18)
Change at Week 28	-3.0 (2.49)	-4.3 (2.26)	-4.4 (2.27)
Change at Week 32	-2.9 (2.51)	-4.1 (2.40)	-4.5 (2.30)
Change at Week 36	-2.8 (2.43)	-4.0 (2.43)	-4.5 (2.40)
Change at Week 40	-2.7 (2.51)	-3.9 (2.46)	-4.5 (2.39)
Change at Week 44	-2.5 (2.52)	-3.9 (2.49)	-4.3 (2.48)

51. Secondary Outcome

Title	Maintenance Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0 or 1, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44
Description	Number of participants in remission based on stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 and who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
	49 28.0%	70 40.7%	84 47.7%

52. Secondary Outcome

Title	Maintenance Study: Number of Participants in Remission Based on Stool Frequency Subscore of 0, Rectal Bleeding Subscore of 0, and Endoscopy Subscore of 0 or 1 at Week 44
Description	Number of participants in remission based on stool frequency subscore of 0 (normal number of stools), rectal bleeding subscore of 0 (no blood seen), and endoscopy subscore of 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]) at Week 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who were missing all 3 of the Mayo subscores related to this OM (stool frequency, rectal bleeding subscore, and Mayo endoscopy subscore) at Week 44 were considered not to be in remission. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
	30 17.1%	42 24.4%	48 27.3%

53. Secondary Outcome

Title	Maintenance Study: Number of Participants in Symptomatic Remission at Week 44
Description	Symptomatic remission was defined as a Mayo stool frequency subscore of 0 (normal number of stools) or 1 (1-2 stools more than normal) and a rectal bleeding subscore of 0 (no blood seen). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 were considered not to be in symptomatic remission from the time of the event onward. Participants who had both stool frequency and rectal bleeding subscores missing at Week 44 were considered not to be in symptomatic remission for that visit. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
	79 45.1%	107 62.2%	119 67.6%

54. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per Global Definition)
Description	Global definition of clinical remission: Mayo score <=2 points, with no individual subscore >1. Mayo score included 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated as 0 (normal) to 3 (severe). Total score =sum of 4 subscores and range from 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. BF: participants received treatment with 1/ more TNF antagonists/ vedolizumab at dose approved for treatment of UC, and did not respond initially or responded initially but lost response/ were intolerant of medication. Participants with prohibited change in UC medication/ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had all 4 Mayo subscores missing at Week 44 considered not in clinical remission. Endoscopy subscore assessed during central review of video of endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM with specified category.

Arm/Group Title		Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:		Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed		175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with BF	Number Analyzed	88 participants	70 participants	91 participants
		15 17.0%	16 22.9%	36 39.6%
Participants without BF	Number Analyzed	87 participants	102 participants	85 participants
		27 31.0%	50 49.0%	41 48.2%

55. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Remission at Week 44 by Biologic Failure Status (As Per US Definition)
Description	US definition of clinical remission: absolute stool number <=3, Mayo rectal bleeding subscore: 0 (no blood seen), Mayo endoscopy subscore: 0(normal/ inactive disease) or 1(mild disease [erythema, decreased vascular pattern, mild friability]). Absolute stool number: average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy subscores: 0(normal) to 3(severe). BF: participants received 1/ more TNF antagonists/ vedolizumab for treatment of UC, not responded initially/ responded initially but lost response/ were intolerant of medicines. Participants with prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect /due to AE of worsening of UC before Week 44 or who were missing all 3 of Mayo components (absolute stool number, rectal bleeding and endoscopy) at Week 44 were not in clinical remission. Endoscopy subscore assessed during central review used video of endoscopy.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM with specified category.

Arm/Group Title		Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:		Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed		175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with BF	Number Analyzed	88 participants	70 participants	91 participants
		15 17.0%	17 24.3%	34 37.4%
Participants without BF	Number Analyzed	87 participants	102 participants	85 participants
		28 32.2%	51 50.0%	41 48.2%

56. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Response up to Week 44 by Biologic Failure Status
Description	Clinical response: decrease from IS baseline in Mayo score by >=30% and >=3 points, with either decrease from baseline in RB subscore >=1/ RB subscore of 0/ 1. Mayo score have 4 subscores (SF, RB, endoscopy findings, PGA), rated 0(normal) to 3(severe). Total score=sum of 4 subscores and range from 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. BF: participants received treatment: 1/ more TNF antagonists/ vedolizumab for treating UC, no respond initially/responded initially but lost response/ medication intolerant. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/ AE of worsen UC before Week 44, had all 4 Mayo subscores miss at Week44/ lost clinical response at any time before Week44 were not in clinical response upto Week44. Endoscopy subscore assessed during central review used endoscopy video.
Time Frame	Up to Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

Arm/Group Title		Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:		Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed		175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with BF	Number Analyzed	88 participants	70 participants	91 participants
		34 38.6%	39 55.7%	59 64.8%
Participants without BF	Number Analyzed	87 participants	102 participants	85 participants
		44 50.6%	78 76.5%	66 77.6%

57. Secondary Outcome

Title	Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 by Biologic Failure Status
Description	Number of participants with endoscopic healing at week 44 by BF status were reported. Endoscopic healing is improvement in endoscopic appearance of mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). BF: participants received treatment with 1 or more tumor necrosis factor (TNF) antagonists or vedolizumab at dose approved for treatment of UC, and either did not respond initially, responded initially but then lost response, or were intolerant of medication. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy, or used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 or who had missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM with specified category.

Arm/Group Title		Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:		Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed		175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
Participants with BF	Number Analyzed	88 participants	70 participants	91 participants
		20 22.7%	18 25.7%	41 45.1%
Participants without BF	Number Analyzed	87 participants	102 participants	85 participants
		30 34.5%	57 55.9%	49 57.6%

58. Secondary Outcome

Title	Maintenance Study: Number of Participants With Endoscopic Healing at Week 44 Among Participants Who Had Achieved Endoscopic Healing at Maintenance Baseline
Description	Endoscopic healing is improvement in the endoscopic appearance of the mucosa. It is defined as Mayo endoscopic subscore = 0 (normal or inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had a missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who had achieved endoscopic healing at maintenance baseline.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	71	68	57
Measure Type: Count of Participants; Unit of Measure: Participants
	25 35.2%	41 60.3%	37 64.9%

59. Secondary Outcome

Title	Maintenance Study: Number of Participants With Normal or Inactive Mucosal Disease at Week 44
Description	Normal or inactive mucosal disease is defined as an endoscopy score of 0. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 or who had a missing endoscopy score at Week 44 were considered not to have endoscopic healing. Endoscopy subscore as assessed during central review of video of endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	175	172	176
Measure Type: Count of Participants; Unit of Measure: Participants
	32 18.3%	41 23.8%	51 29.0%

60. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per Global Definition)
Description	Global definition of clinical remission: Mayo score <=2 points, with no individual subscore >1. Mayo score includes 4 subscores (stool frequency, rectal bleeding, endoscopy findings, physician's global assessment), rated 0(normal) to 3(severe). Total score=sum of 4 subscores, range: 0 to 12, where 3 to 5=mild; 6 to 10=moderate; 11 to 12=severe; higher scores=worsening of disease. Participants with prohibited change in UC medication/ostomy/colectomy/used rescue medication after clinical flare/ discontinued study drug due to lack of therapeutic effect/AE of worsening of UC before Week 44 considered not to achieved OM of clinical remission and not receiving concomitant corticosteroids (corticosteroid-free clinical remission). Participants with all 4 Mayo subscores missing at Week 44 considered not in clinical remission. Participants missing value in corticosteroid use had their last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC with, participants who were receiving concomitant corticosteroids at maintenance baseline.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	91	82	92
Measure Type: Count of Participants; Unit of Measure: Participants
	17 18.7%	25 30.5%	36 39.1%

61. Secondary Outcome

Title	Maintenance Study: Number of Participants With Clinical Remission at Week 44 and Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline (Per US Definition)
Description	US definition of clinical remission: absolute stool number <=3, a Mayo rectal bleeding subscore of 0 (no blood seen), and Mayo endoscopy subscore of 0(normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]), without PGA. Absolute stool number is average of daily stool number over 3 days. Mayo rectal bleeding and endoscopy findings subscores rated as 0 (normal) to 3 (severe). Participants with prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who were missing all 3 of Mayo components related to this OM (absolute stool number, rectal bleeding, and endoscopy subscore) at Week 44 were considered not in clinical remission. Participants with missing value in corticosteroid use had last value carried forward. Endoscopy subscore assessed during central review of video of endoscopy was used.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were receiving concomitant corticosteroids at maintenance baseline.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	91	82	92
Measure Type: Count of Participants; Unit of Measure: Participants
	18 19.8%	27 32.9%	34 37.0%

62. Secondary Outcome

Title	MS: Change From Maintenance Baseline in Average Daily P.Eq Corticosteroid Dose Through Week 44 Among Participants Who Received Corticosteroids Other Than Budesonide and Beclomethasone Dipropionate at Maintenance Baseline
Description	The change from maintenance baseline in average daily prednisone-equivalent (P.Eq) corticosteroid dose through Week 44 among the participants receiving concomitant corticosteroids other than budesonide and beclomethasone dipropionate at maintenance baseline was reported. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing value in corticosteroid use at a timepoint had their last available value carried forward to that timepoint.
Time Frame	Baseline Through Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants who were receiving concomitant corticosteroids at maintenance baseline.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	75	69	82
Mean (Standard Deviation); Unit of Measure: milligram per day (mg/day)
Change at Week 4	-7.4 (5.73)	-7.8 (5.48)	-7.2 (5.42)
Change at Week 8	-10.8 (6.77)	-11.7 (8.17)	-12.1 (6.81)
Change at Week 12	-10.1 (8.71)	-11.6 (9.16)	-12.6 (7.00)
Change at Week 16	-10.1 (7.73)	-12.1 (8.37)	-12.8 (6.98)
Change at Week 20	-9.5 (7.85)	-12.0 (8.44)	-12.6 (7.27)
Change at Week 24	-8.9 (7.96)	-11.9 (8.62)	-12.5 (7.88)
Change at Week 28	-7.8 (8.72)	-11.5 (9.23)	-12.4 (7.56)
Change at Week 32	-7.7 (8.18)	-11.4 (8.98)	-12.1 (8.21)
Change at Week 36	-7.6 (8.28)	-11.3 (8.80)	-11.7 (8.34)
Change at Week 40	-7.2 (8.04)	-11.5 (8.62)	-11.5 (8.37)
Change at Week 44	-6.8 (7.98)	-11.0 (8.87)	-11.5 (8.37)

63. Secondary Outcome

Title	Maintenance Study: Number of Participants Not Receiving Concomitant Corticosteroids at Week 44 Among Participants Who Received Concomitant Corticosteroids at Maintenance Baseline
Description	Number of participants not receiving concomitant corticosteroids at Week 44 among participants who received concomitant corticosteroids at maintenance Baseline were reported. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 considered to be receiving concomitant corticosteroids at Week 44. Participants who had a missing value in corticosteroid use at Week 44 had their last value carried forward.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC with, participants who were receiving concomitant corticosteroids at maintenance baseline.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	91	82	92
Measure Type: Count of Participants; Unit of Measure: Participants
	43 47.3%	56 68.3%	73 79.3%

64. Secondary Outcome

Title	Maintenance Study: Number of Participants Who Maintained 20-point Improvement From Induction Baseline in IBDQ up to Week 44 Among Participants With a >20-point Improvement in IBDQ at Maintenance Baseline
Description	IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as:10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ AE of worsening of UC before Week 44 or who had missing IBDQ score were considered not to have maintained improvement in IBDQ.
Time Frame	Up to Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants with >20-point Improvement in IBDQ at the maintenance baseline.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	129	144	143
Measure Type: Count of Participants; Unit of Measure: Participants
	64 49.6%	95 66.0%	102 71.3%

65. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in the IBDQ Score at Week 20 and 44
Description	IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing IBDQ score at a timepoint had their last value carried forward.
Time Frame	Baseline, Week 20, and 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

Arm/Group Title		Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:		Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed		175	172	176
Mean (Standard Deviation); Unit of Measure: Units on a scale
Change at Week 20	Number Analyzed	174 participants	172 participants	174 participants
		-7.0 (31.37)	0.8 (29.05)	5.5 (27.40)
Change at Week 44	Number Analyzed	173 participants	172 participants	174 participants
		-15.1 (35.43)	-3.0 (32.89)	3.9 (31.54)

66. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in the IBDQ Dimension Scores at Week 20 and 44
Description	The IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. IBDQ consists of 32 items, each item score ranged from 1 (worst possible response) to 7 (best possible response). The 32 items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. Participants who had prohibited change in concomitant UC medication or ostomy or colectomy prior to Week 44 had their Week 0 value of induction study carried forward from time of event onward and participants who had missing IBDQ dimension score at a timepoint had their last available value carried forward.
Time Frame	Baseline, Week 20, and 44

Outcome Measure Data

Analysis Population Description

PEAS included all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM for specified categories at specified timepoint.

Arm/Group Title		Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:		Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed		175	172	176
Mean (Standard Deviation); Unit of Measure: Units on a scale
Bowel:Change at Week 20	Number Analyzed	174 participants	172 participants	174 participants
		-3.2 (10.88)	-0.5 (9.16)	1.3 (9.56)
Bowel:Change at Week 44	Number Analyzed	173 participants	172 participants	174 participants
		-5.7 (12.34)	-1.6 (10.99)	0.8 (10.49)
Emotional: Change at Week 20	Number Analyzed	174 participants	172 participants	174 participants
		-1.9 (12.16)	0.9 (11.12)	2.2 (10.56)
Emotional: Change at Week 44	Number Analyzed	173 participants	172 participants	174 participants
		-4.7 (13.84)	-0.5 (12.17)	1.4 (12.22)
Systemic: Change at Week 20	Number Analyzed	174 participants	172 participants	174 participants
		-1.1 (5.54)	0.0 (5.31)	0.7 (5.24)
Systemic: Change at Week 44	Number Analyzed	173 participants	172 participants	174 participants
		-2.2 (5.52)	-0.5 (5.97)	0.5 (5.83)
Social: Change at Week 20	Number Analyzed	174 participants	172 participants	174 participants
		-0.7 (5.93)	0.3 (6.59)	1.4 (5.44)
Social: Change at Week 44	Number Analyzed	173 participants	172 participants	174 participants
		-2.5 (6.72)	-0.5 (7.10)	1.1 (6.29)

67. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in 36-Item Short-Form (SF-36) Physical Component Score (PCS) and Mental Component Score (MCS) at Weeks 20 and 44
Description	SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Based on scale scores, PCS (calculated from subscales physical functioning, role-physical, bodily pain, and general health) and MCS (calculated from subscales vitality, social functioning, role-emotional and mental health) scores were derived. Summary MCS and PCS score is also scaled from 0 to 100 with higher scores= better health. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC before Week 44 had Week 0 value of IS carried forward from time of event onward and participants with missing component summary score at timepoint had last available value carried forward.
Time Frame	Baseline, Weeks 20, and 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

Arm/Group Title		Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:		Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed		175	172	176
Mean (Standard Deviation); Unit of Measure: Units on a scale
PCS: Change at Week 20	Number Analyzed	173 participants	172 participants	175 participants
		-1.2 (6.20)	-0.2 (6.15)	0.8 (5.55)
PCS: Change at Week 44	Number Analyzed	173 participants	172 participants	175 participants
		-1.7 (6.45)	-0.4 (7.14)	1.3 (5.68)
MCS: Change at Week 20	Number Analyzed	173 participants	172 participants	175 participants
		-1.1 (8.90)	1.0 (8.91)	0.4 (9.10)
MCS: Change at Week 44	Number Analyzed	173 participants	172 participants	175 participants
		-2.4 (9.89)	0.3 (8.41)	0.3 (9.51)

68. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in Individual Subscales of 36-Item Short-Form (SF-36) at Weeks 20 and 44
Description	SF-36 evaluates 8 individual subscales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health). Each 8 scales scored from 0 to 100 with higher scores= better health. Participants who had prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 had Week 0 value of induction study carried forward from time of event onward and participants with missing individual scale score at timepoint had last available value carried forward.
Time Frame	Baseline, Weeks 20, and 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

Arm/Group Title		Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:		Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed		175	172	176
Mean (Standard Deviation); Unit of Measure: Units on a scale
Physical functioning: Change at Week 20	Number Analyzed	173 participants	172 participants	175 participants
		-0.61 (6.140)	-0.01 (5.506)	0.51 (4.809)
Physical functioning: Change at Week 44	Number Analyzed	173 participants	172 participants	175 participants
		-1.40 (5.932)	-0.44 (5.624)	0.66 (4.819)
Role-physical: Change at Week 20	Number Analyzed	173 participants	172 participants	175 participants
		-0.61 (8.630)	0.17 (7.996)	0.23 (8.144)
Role-physical: Change at Week 44	Number Analyzed	173 participants	172 participants	175 participants
		-2.27 (9.400)	-0.84 (8.293)	1.08 (8.096)
Bodily pain:Change at Week 20	Number Analyzed	173 participants	172 participants	175 participants
		-2.80 (9.081)	-0.30 (8.556)	1.06 (8.971)
Bodily pain:Change at Week 44	Number Analyzed	173 participants	172 participants	175 participants
		-2.33 (9.245)	0.23 (9.340)	0.94 (8.350)
General health:Change at Week 20	Number Analyzed	173 participants	172 participants	175 participants
		-0.95 (7.468)	0.67 (7.802)	1.14 (7.133)
General health:Change at Week 44	Number Analyzed	173 participants	172 participants	175 participants
		-1.62 (7.449)	0.24 (8.722)	1.92 (7.955)
Vitality:Change at Week 20	Number Analyzed	173 participants	172 participants	175 participants
		-1.71 (8.876)	0.74 (8.917)	0.39 (9.209)
Vitality:Change at Week 44	Number Analyzed	173 participants	172 participants	175 participants
		-3.18 (10.389)	0.11 (9.152)	0.53 (9.743)
Social functioning: Change at Week 20	Number Analyzed	173 participants	172 participants	175 participants
		-0.87 (9.245)	0.47 (8.979)	0.72 (9.907)
Social functioning: Change at Week 44	Number Analyzed	173 participants	172 participants	175 participants
		-1.83 (10.186)	0.06 (9.515)	1.12 (9.678)
Role-emotional: Change at Week 20	Number Analyzed	173 participants	172 participants	175 participants
		-0.93 (9.586)	0.47 (9.338)	0.14 (8.637)
Role-emotional: Change at Week 44	Number Analyzed	173 participants	172 participants	175 participants
		-2.21 (10.187)	0.04 (9.324)	0.10 (8.199)
Mental health:Change at Week 20	Number Analyzed	173 participants	172 participants	175 participants
		-1.07 (9.085)	1.08 (8.631)	0.61 (8.467)
Mental health:Change at Week 44	Number Analyzed	173 participants	172 participants	175 participants
		-2.15 (9.992)	0.06 (8.042)	0.53 (8.915)

69. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 Dimensions (EQ-5D) Health Questionnaire Index Score at Weeks 20 and 44
Description	EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing individual scale score at a timepoint had their last available value carried forward.
Time Frame	Baseline, Weeks 20, and 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

Arm/Group Title		Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:		Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed		175	172	176
Mean (Standard Deviation); Unit of Measure: Units on a scale
Change at Week 20	Number Analyzed	173 participants	172 participants	175 participants
		-0.036 (0.1535)	-0.002 (0.1694)	0.016 (0.1471)
Change at Week 44	Number Analyzed	173 participants	172 participants	175 participants
		-0.048 (0.1587)	0.008 (0.1656)	0.025 (0.1674)

70. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Health State Visual Analog Scale (VAS) Score at Weeks 20 and 44
Description	The EQ-5D VAS records the participant's self-rated health on a vertical, VAS, with 0 representing the worst imaginable health state and 100 representing the best imaginable health state. The EQ VAS is used as a quantitative measure of health outcome as judged by the individual participant. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward and participants who had a missing VAS score at a timepoint had their last available value carried forward.
Time Frame	Baseline, Weeks 20 and 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants analyzed for this OM at specified timepoint.

Arm/Group Title		Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:		Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed		175	172	176
Mean (Standard Deviation); Unit of Measure: Units on a scale
Change at Week 20	Number Analyzed	173 participants	172 participants	175 participants
		-4.0 (16.70)	-0.3 (17.29)	2.6 (17.80)
Change at Week 44	Number Analyzed	173 participants	172 participants	175 participants
		-7.7 (18.75)	-2.2 (19.87)	2.4 (17.28)

71. Secondary Outcome

Title	Maintenance Study: Percentage of Participants With Change From Maintenance Baseline in EuroQOL-5 (EQ-5D) Dimensions Score at Weeks 20 and 44
Description	EQ-5D descriptive system comprises of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels of perceived problems (1-no problem, 2-slight problems, 3-moderate problems, 4-severe problems, 5-extreme problems). The responses to 5 EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 (death) to 1 (full health). Participants who had prohibited change in concomitant UC medication/ostomy/ colectomy/ used rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to AE of worsening of UC prior to Week 44 had their Week 0 value of induction study carried forward from time of event onward and who had missing individual scale score at timepoint had their last available value carried forward. Percentage of participants with various responses to the 5 dimensions were reported.
Time Frame	Baseline, Weeks 20, and 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

Arm/Group Title		Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:		Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed		175	172	176
Measure Type: Number; Unit of Measure: Percentage of participants
Change at Week (W) 20: Mobility:Improved	Number Analyzed	173 participants	172 participants	175 participants
		12.7	10.5	13.7
Change at W 20:Mobility:No change	Number Analyzed	173 participants	172 participants	175 participants
		75.7	79.1	78.9
Change at W 20:Mobility:Worsened	Number Analyzed	173 participants	172 participants	175 participants
		11.6	10.5	7.4
Change at W 44:Mobility:Improved	Number Analyzed	173 participants	172 participants	175 participants
		9.8	11.6	12.0
Change at W 44:Mobility:No change	Number Analyzed	173 participants	172 participants	175 participants
		75.1	76.2	79.4
Change at W 44:Mobility:Worsened	Number Analyzed	173 participants	172 participants	175 participants
		15.0	12.2	8.6
Change at W 20:Self-care:Improved	Number Analyzed	173 participants	172 participants	174 participants
		1.7	1.7	4.0
Change at W 20:Self-care:No change	Number Analyzed	173 participants	172 participants	174 participants
		91.9	93.6	93.7
Change at W 20:Self-care:Worsened	Number Analyzed	173 participants	172 participants	174 participants
		6.4	4.7	2.3
Change at W 44:Self-care:Improved	Number Analyzed	173 participants	172 participants	175 participants
		1.7	2.3	4.0
Change at W 44:Self-care:No change	Number Analyzed	173 participants	172 participants	175 participants
		95.4	93.0	93.1
Change at W 44:Self-care:Worsened	Number Analyzed	173 participants	172 participants	175 participants
		2.9	4.7	2.9
Change at W 20:Usual activities:Improved	Number Analyzed	173 participants	172 participants	175 participants
		12.7	17.4	22.3
Change at W 20:Usual activities:No Change	Number Analyzed	173 participants	172 participants	175 participants
		64.2	66.9	64.0
Change at W 20:Usual activities:Worsened	Number Analyzed	173 participants	172 participants	175 participants
		23.1	15.7	13.7
Change at W 44: Usual activities:Improved	Number Analyzed	173 participants	172 participants	175 participants
		14.5	24.4	25.1
Change at W 44:Usual activities:No Change	Number Analyzed	173 participants	172 participants	175 participants
		52.6	55.2	62.9
Change at W 44:Usual activities:Worsened	Number Analyzed	173 participants	172 participants	175 participants
		32.9	20.3	12.0
Change at W 20:Pain/discomfort: Improved	Number Analyzed	173 participants	172 participants	175 participants
		16.8	22.1	23.4
Change at W 20:Pain/discomfort: No Change	Number Analyzed	173 participants	172 participants	175 participants
		54.9	58.7	58.9
Change at W 20:Pain/discomfort: Worsened	Number Analyzed	173 participants	172 participants	175 participants
		28.3	19.2	17.7
Change at W 44:Pain/discomfort: Improved	Number Analyzed	173 participants	172 participants	175 participants
		17.9	25.0	30.3
Change at W 44:Pain/discomfort: No Change	Number Analyzed	173 participants	172 participants	175 participants
		46.2	55.8	50.9
Change at W 44:Pain/discomfort: Worsened	Number Analyzed	173 participants	172 participants	175 participants
		35.8	19.2	18.9
Change at W 20:Anxiety/depression: Improved	Number Analyzed	173 participants	172 participants	175 participants
		16.2	20.3	24.6
Change at W 20:Anxiety/depression: No Change	Number Analyzed	173 participants	172 participants	175 participants
		62.4	61.6	58.3
Change at W 20:Anxiety/depression: Worsened	Number Analyzed	173 participants	172 participants	175 participants
		21.4	18.0	17.1
Change at W 44:Anxiety/depression: Improved	Number Analyzed	173 participants	172 participants	175 participants
		17.9	20.3	26.9
Change at W 44:Anxiety/depression: No Change	Number Analyzed	173 participants	172 participants	175 participants
		56.1	58.7	58.9
Change at W 44:Anxiety/depression: Worsened	Number Analyzed	173 participants	172 participants	175 participants
		26.0	20.9	14.3

72. Secondary Outcome

Title	Maintenance Study: Number of Participants With Mucosal Healing at Week 44
Description	Mucosal healing included EH and HH. EH: endoscopy subscore of 0 (normal/ inactive disease) or 1 (mild disease [erythema, decreased vascular pattern, mild friability]). HH: neutrophil infiltration in <5% of crypts, no crypt destruction, no erosions/ ulcerations/ granulation tissue. Participants with prohibited change in concomitant UC medication/ ostomy/ colectomy/ used rescue medication after clinical flare/ discontinued study agent due to lack of therapeutic effect/ due to AE of worsening of UC prior to Week 44/ missing endoscopy score/ missing any component of histologic healing (i.e. assessment of neutrophils in crypts, crypt destruction/ erosions/ ulcerations/ granulations) at Week 44 and had unevaluable biopsy (biopsy collected but could not assessed due to sample preparation/ technical errors) at Week 44, but who did not achieve endoscopic healing, considered not to have mucosal healing. Endoscopy subscore assessed during central review used endoscopy video.
Time Frame	Week 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC, with participants whose mucosal healing status was determined at Week 44 with evaluable biopsy.

Arm/Group Title	Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:	Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed	170	170	172
Measure Type: Count of Participants; Unit of Measure: Participants
	41 24.1%	66 38.8%	79 45.9%

73. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in C-reactive Protein (CRP) Concentration at Weeks 8, 24, and 44
Description	Change from Maintenance baseline in CRP concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing CRP value at the designated analysis timepoint had their last value carried forward.
Time Frame	Baseline, Weeks 8, 24, and 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

Arm/Group Title		Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:		Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed		175	172	176
Median (Inter-Quartile Range); Unit of Measure: milligram per liter (mg/L)
Change at Week 8	Number Analyzed	174 participants	170 participants	176 participants
		0.05; (-0.67 to 0.81)	-0.03; (-0.92 to 0.37)	-0.04; (-1.50 to 0.92)
Change at Week 24	Number Analyzed	174 participants	170 participants	176 participants
		0.68; (-0.28 to 2.34)	0.13; (-0.75 to 1.16)	-0.03; (-1.53 to 0.59)
Change at Week 44	Number Analyzed	174 participants	170 participants	175 participants
		1.07; (0.00 to 5.18)	0.38; (-0.35 to 1.53)	-0.07; (-1.73 to 0.79)

74. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in Fecal Lactoferrin Concentration at Weeks 8, 24, and 44
Description	Change from Maintenance baseline in fecal lactoferrin concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing fecal lactoferrin value at the designated analysis timepoint had their last value carried forward.
Time Frame	Baseline, Weeks 8, 24, and 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

Arm/Group Title		Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:		Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed		175	172	176
Median (Inter-Quartile Range); Unit of Measure: microgram per gram (mcg/g)
Change at Week 8	Number Analyzed	167 participants	161 participants	163 participants
		0.0; (-44.8 to 72.0)	0.0; (-35.0 to 48.5)	-1.4; (-52.0 to 30.9)
Change at Week 24	Number Analyzed	166 participants	161 participants	161 participants
		2.2; (-45.3 to 139.9)	-0.8; (-47.9 to 35.1)	-2.3; (-65.5 to 25.5)
Change at Week 44	Number Analyzed	166 participants	159 participants	160 participants
		0.8; (-34.2 to 177.4)	-1.9; (-54.4 to 35.1)	-9.1; (-101.6 to 7.8)

75. Secondary Outcome

Title	Maintenance Study: Change From Maintenance Baseline in Fecal Calprotectin Concentration at Weeks 8, 24, and 44
Description	Change from Maintenance baseline in fecal calprotectin concentration at Weeks 8, 24, and 44 were reported. Participants who had a prohibited change in concomitant UC medication or an ostomy or colectomy, or used a rescue medication after clinical flare, or discontinued study agent due to lack of therapeutic effect or due to an AE of worsening of UC prior to the Week 44 had their Week 0 value of the induction study carried forward from the time of the event onward. Participants who had a missing fecal calprotectin value at the designated analysis timepoint had their last value carried forward.
Time Frame	Baseline, Weeks 8, 24, and 44

Outcome Measure Data

Analysis Population Description

PEAS consisted of all participants who were in clinical response to IV ustekinumab induction and were randomized at Week 0 of the maintenance study to ustekinumab 90 mg SC q8w, ustekinumab 90 mg SC q12w, or placebo SC. Here, n (number of participants analyzed) signifies participants who were analyzed for this OM at specified timepoint.

Arm/Group Title		Maintenance Study (MS): Placebo Subcutaneous (SC)	MS: Ustekinumab 90 mg SC Every 12 Weeks (q12w)	MS: Ustekinumab 90 mg SC Every 8 Weeks (q8w)
Arm/Group Description:		Participants who were randomized to receive ustekinumab (i.e., 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive placebo subcutaneous (SC), beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.	Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.
Overall Number of Participants Analyzed		175	172	176
Mean (Inter-Quartile Range); Unit of Measure: milligram per kilogram (mg/kg)
Change at Week 8	Number Analyzed	168 participants	160 participants	161 participants
		0.0; (-158.0 to 557.0)	-18.5; (-368.5 to 225.5)	-31.0; (-380.0 to 205.0)
Change at Week 24	Number Analyzed	165 participants	160 participants	159 participants
		125.0; (-97.0 to 1223.0)	-31.5; (-413.5 to 385.0)	-46.0; (-530.0 to 318.0)
Change at Week 44	Number Analyzed	164 participants	158 participants	159 participants
		229.5; (-102.5 to 1387.0)	-37.5; (-476.0 to 274.0)	-85.0; (-742.0 to 166.0)

Adverse Events

Time Frame

Up to Week 220

Adverse Event Reporting Description

The safety analysis set included participants who received at least 1 dose of study agent, including partial dose, according to actual treatment received.

Arm/Group Title

Induction Study(IS): Placebo Intravenous (IV)

IS: Ustekinumab 130 Milligram (mg) IV

IS: Ustekinumab Approximately 6mg/kg IV

IS: Placebo-Nonresponders at Week 8

IS: Ustekinumab Nonresponders at Week 8

Maintenance Study(MS): Placebo Subcutaneous (SC)

MS: Ustekinumab 90mg SC Every 12 Weeks (q12w)

MS: Ustekinumab 90mg SC Every 8 Weeks (q8w)

MS: Placebo IV (IS - Responders) to Placebo SC

MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w

Long Term Extension (LTE): Placebo SC

LTE: Placebo SC to Ustekinumab SC 90 mg q8w

LTE: Ustekinumab 90 mg SC q12w

LTE: Ustekinumab 90 mg SC q12w to 90 mg SC q8w

LTE: Ustekinumab 90 mg SC q8w

LTE: Ustekinumab 90 mg SC q8w to 90 mg SC q8w

LTE: Placebo IV (IS - Responders) to Placebo SC

LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w

Arm/Group Description

Participants received single dose of placebo as intravenous (IV) infusion at Week 0. Participants with clinical response at Week (W) 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received weight-range based dose of ustekinumab approximating 6 mg/kg IV + placebo SC at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.

Participants received single dose of ustekinumab 130 mg as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.

Participants received weight range based dose of ustekinumab approximating 6 milligram per kilogram (mg/kg) (ustekinumab 260 mg [body weight <=55 kg], 390 mg [body weight >55 kg but ≤85 kg] and 520 mg [body weight >85 kg]), as IV infusion at Week 0. Participants with clinical response at Week 8 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 8 received 1 dose of ustekinumab 90 mg SC+ placebo IV at Week 8. At Week 16, participants who did not achieve clinical response at Week 8 were re-evaluated for clinical response. Participants with clinical response at Week 16 were eligible to enter the maintenance study. Participants who did not achieve clinical response at Week 16 were not eligible to enter the maintenance study and had a safety follow-up visit up to 20 weeks after their last dose of study agent.

Participants who did not achieve clinical response to placebo IV at Week 8 and received a single IV infusion of ustekinumab approximating 6 mg/kg at Week 8. Included data from Week 8 onward through the final safety visit.

Participants who did not achieve clinical response to ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 and received a single dose of ustekinumab 90 mg SC along with matching placebo IV (to maintain the blind). Participants with clinical response at Week 16 (that is, delayed responders) were eligible to enter Maintenance study, but were not be randomized. Included data from Week 8 onward through the final safety visit.

Participants in clinical response (at Week 8 or Week 16) to Induction treatment with single IV infusion of Ustekinumab who were randomized to receive placebo subcutaneously, beginning Week 0 of Maintenance study through Week 44.

Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) beginning at Week 0 of maintenance study through Week 44.

Participants who were randomized to receive ustekinumab (ie, 130 mg IV or approximately 6 mg/kg IV) at Week 0 of the induction study and were in clinical response at induction Week 8 and participants who were randomized to receive placebo at Week 0 of the induction study and were not in clinical response at induction Week 8 but were in clinical response at induction Week 16 after receiving a dose of IV ustekinumab (approximately 6 mg/kg) at induction Week 8 (placebo to ustekinumab 6 mg/kg IV) were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w), beginning at Week 0 of maintenance study through Week 44.

Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).

Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC every 8 weeks, beginning at Week 0 of maintenance study through Week 44 (non-randomized participants).

Participants who were randomized to receive placebo SC in the maintenance study and received placebo SC at the first dosing visit (Week 48) of long term extension (LTE).

Participants who were randomized to receive placebo SC in the maintenance study and had a dose adjustment from placebo SC to ustekinumab 90 mg SC every 8 weeks (q8w) during the LTE.

Participants who were randomized to receive ustekinumab 90 mg SC every 12 weeks (q12w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.

Participants who received ustekinumab 90 mg SC every 12 weeks (q12w) completed the maintenance Week 44 visit and benefited from continued treatment entered the LTE period, and received ustekinumab 90 mg at Week 48 until Week 220.

Participants who were randomized to receive ustekinumab 90 mg SC every 8 weeks (q8w) in the maintenance study and received ustekinumab 90 mg SC at the first dosing visit (Week 48) of the LTE.

Participants who were randomized to receive ustekinumab 90 mg SC q8w in the maintenance study and had a sham dose adjustment to ustekinumab 90 mg SC q8w during the LTE.

Participants with clinical response to Induction Week 0 treatment with placebo IV received placebo SC in the maintenance study and the LTE through Week 200 (non-randomized participants).

Participants who were delayed responders to ustekinumab induction (were not in clinical response to induction treatment ustekinumab (130 mg or approximately 6 mg/kg [IV]) at Week 8 but were in clinical response at Week 16, after receiving ustekinumab 90 mg SC at Week 8) and received ustekinumab 90 mg SC q8w in the maintenance study and the LTE through Week 200 (non-randomized participants).

All-Cause Mortality

Induction Study(IS): Placebo Intravenous (IV)

IS: Ustekinumab 130 Milligram (mg) IV

IS: Ustekinumab Approximately 6mg/kg IV

IS: Placebo-Nonresponders at Week 8

IS: Ustekinumab Nonresponders at Week 8

Maintenance Study(MS): Placebo Subcutaneous (SC)

MS: Ustekinumab 90mg SC Every 12 Weeks (q12w)

MS: Ustekinumab 90mg SC Every 8 Weeks (q8w)

MS: Placebo IV (IS - Responders) to Placebo SC

MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w

Long Term Extension (LTE): Placebo SC

LTE: Placebo SC to Ustekinumab SC 90 mg q8w

LTE: Ustekinumab 90 mg SC q12w

LTE: Ustekinumab 90 mg SC q12w to 90 mg SC q8w

LTE: Ustekinumab 90 mg SC q8w

LTE: Ustekinumab 90 mg SC q8w to 90 mg SC q8w

LTE: Placebo IV (IS - Responders) to Placebo SC

LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

0/319 (0.00%)

0/321 (0.00%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

1/157 (0.64%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Serious Adverse Events

Induction Study(IS): Placebo Intravenous (IV)

IS: Ustekinumab 130 Milligram (mg) IV

IS: Ustekinumab Approximately 6mg/kg IV

IS: Placebo-Nonresponders at Week 8

IS: Ustekinumab Nonresponders at Week 8

Maintenance Study(MS): Placebo Subcutaneous (SC)

MS: Ustekinumab 90mg SC Every 12 Weeks (q12w)

MS: Ustekinumab 90mg SC Every 8 Weeks (q8w)

MS: Placebo IV (IS - Responders) to Placebo SC

MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w

Long Term Extension (LTE): Placebo SC

LTE: Placebo SC to Ustekinumab SC 90 mg q8w

LTE: Ustekinumab 90 mg SC q12w

LTE: Ustekinumab 90 mg SC q12w to 90 mg SC q8w

LTE: Ustekinumab 90 mg SC q8w

LTE: Ustekinumab 90 mg SC q8w to 90 mg SC q8w

LTE: Placebo IV (IS - Responders) to Placebo SC

LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

22/319 (6.90%)

12/321 (3.74%)

11/320 (3.44%)

7/184 (3.80%)

12/233 (5.15%)

17/175 (9.71%)

13/172 (7.56%)

15/176 (8.52%)

8/103 (7.77%)

11/157 (7.01%)

6/115 (5.22%)

8/56 (14.29%)

13/141 (9.22%)

6/64 (9.38%)

15/143 (10.49%)

3/37 (8.11%)

10/73 (13.70%)

14/116 (12.07%)

Blood and lymphatic system disorders

Anaemia * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

2/172 (1.16%)

0/176 (0.00%)

1/103 (0.97%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

1/73 (1.37%)

0/116 (0.00%)

Autoimmune Haemolytic Anaemia * 1

0/319 (0.00%)

1/321 (0.31%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Iron Deficiency Anaemia * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Cardiac disorders

Acute Myocardial Infarction * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Atrial Fibrillation * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

1/103 (0.97%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Cardiac Arrest * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Coronary Artery Disease * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

1/73 (1.37%)

0/116 (0.00%)

Myocardial Infarction * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pericarditis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

1/115 (0.87%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Congenital, familial and genetic disorders

Hydrocele * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

1/64 (1.56%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Ear and labyrinth disorders

Deafness Neurosensory * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Deafness Unilateral * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Eye disorders

Cataract * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

1/64 (1.56%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Retinal Detachment * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

1/64 (1.56%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Gastrointestinal disorders

Abdominal Pain * 1

0/319 (0.00%)

0/321 (0.00%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Abdominal Pain Upper * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Anal Fissure * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Anorectal Disorder * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Colitis Ulcerative * 1

11/319 (3.45%)

4/321 (1.25%)

4/320 (1.25%)

5/184 (2.72%)

4/233 (1.72%)

8/175 (4.57%)

1/172 (0.58%)

2/176 (1.14%)

3/103 (2.91%)

7/157 (4.46%)

3/115 (2.61%)

2/56 (3.57%)

1/141 (0.71%)

3/64 (4.69%)

5/143 (3.50%)

1/37 (2.70%)

4/73 (5.48%)

2/116 (1.72%)

Colon Dysplasia * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

1/233 (0.43%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Diarrhoea Haemorrhagic * 1

0/319 (0.00%)

0/321 (0.00%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Duodenal Ulcer * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Enteritis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

1/172 (0.58%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Enterovesical Fistula * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Gastrointestinal Haemorrhage * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Inguinal Hernia * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Large Intestinal Obstruction * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

1/73 (1.37%)

0/116 (0.00%)

Large Intestine Perforation * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Large Intestine Polyp * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

1/233 (0.43%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Mesenteric Fibrosis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

1/172 (0.58%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Oesophageal Varices Haemorrhage * 1

0/319 (0.00%)

0/321 (0.00%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pancreatitis Acute * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pseudopolyposis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

1/73 (1.37%)

0/116 (0.00%)

Small Intestinal Obstruction * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Subileus * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

1/157 (0.64%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Umbilical Hernia * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Vomiting * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

General disorders

Non-Cardiac Chest Pain * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pyrexia * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Hepatobiliary disorders

Cholecystitis Acute * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Cholelithiasis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Drug-Induced Liver Injury * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Liver Disorder * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Immune system disorders

Anaphylactic Reaction * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Infections and infestations

Anal Abscess * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Appendicitis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

1/103 (0.97%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Cellulitis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

1/73 (1.37%)

1/116 (0.86%)

Clostridium Difficile Infection * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Complicated Appendicitis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Cystitis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Cytomegalovirus Colitis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

2/172 (1.16%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Cytomegalovirus Infection * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

2/56 (3.57%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Diverticulitis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

1/172 (0.58%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Gastroenteritis * 1

0/319 (0.00%)

1/321 (0.31%)

0/320 (0.00%)

0/184 (0.00%)

1/233 (0.43%)

1/175 (0.57%)

0/172 (0.00%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Gastroenteritis Salmonella * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

1/184 (0.54%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Hepatitis C * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Herpes Zoster * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Human Herpesvirus 6 Infection * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Influenza * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

1/172 (0.58%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Listeriosis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Neutropenic Sepsis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Oral Herpes * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pelvic Inflammatory Disease * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Periorbital Cellulitis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Perirectal Abscess * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Pharyngeal Abscess * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pneumonia * 1

0/319 (0.00%)

1/321 (0.31%)

0/320 (0.00%)

1/184 (0.54%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

1/157 (0.64%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pneumonia Legionella * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

1/184 (0.54%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pneumonia Viral * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

1/115 (0.87%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pyelonephritis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

1/233 (0.43%)

0/175 (0.00%)

1/172 (0.58%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Salpingitis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Salpingo-Oophoritis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Subcutaneous Abscess * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Tooth Abscess * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

1/73 (1.37%)

0/116 (0.00%)

Injury, poisoning and procedural complications

Ankle Fracture * 1

0/319 (0.00%)

0/321 (0.00%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Bladder Injury * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Clavicle Fracture * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Fibula Fracture * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Hip Fracture * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Injury * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

1/103 (0.97%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Jaw Fracture * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

1/37 (2.70%)

0/73 (0.00%)

0/116 (0.00%)

Lumbar Vertebral Fracture * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Meniscus Injury * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Procedural Intestinal Perforation * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Radius Fracture * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

1/157 (0.64%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Rib Fracture * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Spinal Compression Fracture * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Tibia Fracture * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Traumatic Fracture * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Metabolism and nutrition disorders

Diabetic Metabolic Decompensation * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Failure to Thrive * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Musculoskeletal and connective tissue disorders

Enthesopathy * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

1/64 (1.56%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Intervertebral Disc Protrusion * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

1/172 (0.58%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Osteoarthritis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Rotator Cuff Syndrome * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Sacroiliitis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

1/64 (1.56%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Basal Cell Carcinoma * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

1/157 (0.64%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

2/116 (1.72%)

Bowen's Disease * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Colon Adenoma * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Colon Cancer * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Colorectal Cancer * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Hepatic Adenoma * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

1/115 (0.87%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Intraductal Papilloma of Breast * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

1/172 (0.58%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Lentigo Maligna * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

1/73 (1.37%)

0/116 (0.00%)

Ovarian Adenoma * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pituitary Tumour Benign * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Prostate Cancer * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

1/233 (0.43%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Rectal Adenocarcinoma * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

1/233 (0.43%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Rectal Adenoma * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Rectal Cancer * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Skin Papilloma * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

1/172 (0.58%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Testis Cancer * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

1/103 (0.97%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Nervous system disorders

Aphasia * 1

0/319 (0.00%)

1/321 (0.31%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Cognitive Disorder * 1

0/319 (0.00%)

1/321 (0.31%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Epilepsy * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Generalised Tonic-Clonic Seizure * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Ischaemic Stroke * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Migraine * 1

0/319 (0.00%)

0/321 (0.00%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Motor Dysfunction * 1

0/319 (0.00%)

1/321 (0.31%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Optic Neuritis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

1/115 (0.87%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Presyncope * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

1/233 (0.43%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pregnancy, puerperium and perinatal conditions

Abortion Spontaneous * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

2/176 (1.14%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

1/64 (1.56%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Psychiatric disorders

Confusional State * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

1/103 (0.97%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Mental Status Changes * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Suicidal Ideation * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

1/37 (2.70%)

0/73 (0.00%)

0/116 (0.00%)

Renal and urinary disorders

Acute Kidney Injury * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Calculus Bladder * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

1/73 (1.37%)

0/116 (0.00%)

Chronic Kidney Disease * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Glomerulonephritis Chronic * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Nephrolithiasis * 1

0/319 (0.00%)

1/321 (0.31%)

0/320 (0.00%)

1/184 (0.54%)

1/233 (0.43%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Renal Colic * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Ureterolithiasis * 1

0/319 (0.00%)

0/321 (0.00%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

2/116 (1.72%)

Urinary Incontinence * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

1/233 (0.43%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Reproductive system and breast disorders

Benign Prostatic Hyperplasia * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Ovarian Cyst * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

1/73 (1.37%)

0/116 (0.00%)

Prostatitis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Respiratory, thoracic and mediastinal disorders

Acute Respiratory Failure * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

1/157 (0.64%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Bronchiectasis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Hyperventilation * 1

0/319 (0.00%)

2/321 (0.62%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pleurisy * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pulmonary Embolism * 1

0/319 (0.00%)

0/321 (0.00%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

1/172 (0.58%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

1/73 (1.37%)

0/116 (0.00%)

Pulmonary Eosinophilia * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

1/233 (0.43%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Skin and subcutaneous tissue disorders

Dermatitis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pyoderma Gangrenosum * 1

1/319 (0.31%)

0/321 (0.00%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Rash * 1

0/319 (0.00%)

1/321 (0.31%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Vascular disorders

Deep Vein Thrombosis * 1

0/319 (0.00%)

0/321 (0.00%)

2/320 (0.63%)

0/184 (0.00%)

1/233 (0.43%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Extremity Necrosis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

1/73 (1.37%)

0/116 (0.00%)

Haemorrhage * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Vasculitis * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

1 Term from vocabulary, MedDRA Version 24.1; * Indicates events were collected by non-systematic assessment

Other (Not Including Serious) Adverse Events

Frequency Threshold for Reporting Other Adverse Events

3%

Induction Study(IS): Placebo Intravenous (IV)

IS: Ustekinumab 130 Milligram (mg) IV

IS: Ustekinumab Approximately 6mg/kg IV

IS: Placebo-Nonresponders at Week 8

IS: Ustekinumab Nonresponders at Week 8

Maintenance Study(MS): Placebo Subcutaneous (SC)

MS: Ustekinumab 90mg SC Every 12 Weeks (q12w)

MS: Ustekinumab 90mg SC Every 8 Weeks (q8w)

MS: Placebo IV (IS - Responders) to Placebo SC

MS: Ustekinumab Delayed Responders(IS) to UST 90mg SC q8w

Long Term Extension (LTE): Placebo SC

LTE: Placebo SC to Ustekinumab SC 90 mg q8w

LTE: Ustekinumab 90 mg SC q12w

LTE: Ustekinumab 90 mg SC q12w to 90 mg SC q8w

LTE: Ustekinumab 90 mg SC q8w

LTE: Ustekinumab 90 mg SC q8w to 90 mg SC q8w

LTE: Placebo IV (IS - Responders) to Placebo SC

LTE: Ustekinumab Delayed Responders (IS) to UST 90mg SC q8w

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Affected / at Risk (%)

Total

91/319 (28.53%)

100/321 (31.15%)

103/320 (32.19%)

27/184 (14.67%)

30/233 (12.88%)

121/175 (69.14%)

93/172 (54.07%)

118/176 (67.05%)

69/103 (66.99%)

93/157 (59.24%)

68/115 (59.13%)

48/56 (85.71%)

98/141 (69.50%)

38/64 (59.38%)

105/143 (73.43%)

27/37 (72.97%)

45/73 (61.64%)

91/116 (78.45%)

Blood and lymphatic system disorders

Anaemia * 1

11/319 (3.45%)

7/321 (2.18%)

8/320 (2.50%)

4/184 (2.17%)

1/233 (0.43%)

12/175 (6.86%)

7/172 (4.07%)

7/176 (3.98%)

9/103 (8.74%)

9/157 (5.73%)

1/115 (0.87%)

3/56 (5.36%)

4/141 (2.84%)

3/64 (4.69%)

2/143 (1.40%)

1/37 (2.70%)

3/73 (4.11%)

4/116 (3.45%)

Leukopenia * 1

1/319 (0.31%)

2/321 (0.62%)

5/320 (1.56%)

0/184 (0.00%)

1/233 (0.43%)

3/175 (1.71%)

2/172 (1.16%)

3/176 (1.70%)

4/103 (3.88%)

5/157 (3.18%)

0/115 (0.00%)

2/56 (3.57%)

3/141 (2.13%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

2/73 (2.74%)

3/116 (2.59%)

Neutropenia * 1

1/319 (0.31%)

0/321 (0.00%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

1/172 (0.58%)

2/176 (1.14%)

3/103 (2.91%)

4/157 (2.55%)

1/115 (0.87%)

2/56 (3.57%)

1/141 (0.71%)

0/64 (0.00%)

2/143 (1.40%)

0/37 (0.00%)

0/73 (0.00%)

3/116 (2.59%)

Eye disorders

Cataract * 1

0/319 (0.00%)

0/321 (0.00%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

2/172 (1.16%)

1/176 (0.57%)

1/103 (0.97%)

3/157 (1.91%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

2/64 (3.13%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Gastrointestinal disorders

Abdominal Distension * 1

0/319 (0.00%)

2/321 (0.62%)

0/320 (0.00%)

0/184 (0.00%)

1/233 (0.43%)

4/175 (2.29%)

2/172 (1.16%)

5/176 (2.84%)

1/103 (0.97%)

1/157 (0.64%)

0/115 (0.00%)

3/56 (5.36%)

2/141 (1.42%)

0/64 (0.00%)

5/143 (3.50%)

0/37 (0.00%)

0/73 (0.00%)

3/116 (2.59%)

Abdominal Pain * 1

9/319 (2.82%)

8/321 (2.49%)

5/320 (1.56%)

0/184 (0.00%)

0/233 (0.00%)

4/175 (2.29%)

6/172 (3.49%)

8/176 (4.55%)

3/103 (2.91%)

5/157 (3.18%)

2/115 (1.74%)

1/56 (1.79%)

2/141 (1.42%)

2/64 (3.13%)

15/143 (10.49%)

1/37 (2.70%)

4/73 (5.48%)

5/116 (4.31%)

Abdominal Pain Upper * 1

0/319 (0.00%)

4/321 (1.25%)

1/320 (0.31%)

0/184 (0.00%)

2/233 (0.86%)

1/175 (0.57%)

0/172 (0.00%)

4/176 (2.27%)

1/103 (0.97%)

1/157 (0.64%)

3/115 (2.61%)

2/56 (3.57%)

4/141 (2.84%)

1/64 (1.56%)

2/143 (1.40%)

1/37 (2.70%)

1/73 (1.37%)

2/116 (1.72%)

Colitis Ulcerative * 1

8/319 (2.51%)

5/321 (1.56%)

5/320 (1.56%)

1/184 (0.54%)

3/233 (1.29%)

48/175 (27.43%)

19/172 (11.05%)

16/176 (9.09%)

25/103 (24.27%)

23/157 (14.65%)

23/115 (20.00%)

11/56 (19.64%)

34/141 (24.11%)

20/64 (31.25%)

37/143 (25.87%)

13/37 (35.14%)

27/73 (36.99%)

30/116 (25.86%)

Constipation * 1

1/319 (0.31%)

1/321 (0.31%)

1/320 (0.31%)

1/184 (0.54%)

0/233 (0.00%)

6/175 (3.43%)

0/172 (0.00%)

3/176 (1.70%)

1/103 (0.97%)

0/157 (0.00%)

1/115 (0.87%)

1/56 (1.79%)

1/141 (0.71%)

0/64 (0.00%)

5/143 (3.50%)

1/37 (2.70%)

0/73 (0.00%)

2/116 (1.72%)

Diarrhoea * 1

1/319 (0.31%)

3/321 (0.93%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

2/175 (1.14%)

5/172 (2.91%)

7/176 (3.98%)

2/103 (1.94%)

6/157 (3.82%)

2/115 (1.74%)

1/56 (1.79%)

6/141 (4.26%)

3/64 (4.69%)

13/143 (9.09%)

2/37 (5.41%)

4/73 (5.48%)

9/116 (7.76%)

Frequent Bowel Movements * 1

0/319 (0.00%)

3/321 (0.93%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

1/172 (0.58%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

1/141 (0.71%)

0/64 (0.00%)

0/143 (0.00%)

2/37 (5.41%)

0/73 (0.00%)

2/116 (1.72%)

Nausea * 1

7/319 (2.19%)

8/321 (2.49%)

7/320 (2.19%)

3/184 (1.63%)

3/233 (1.29%)

4/175 (2.29%)

4/172 (2.33%)

6/176 (3.41%)

3/103 (2.91%)

5/157 (3.18%)

2/115 (1.74%)

1/56 (1.79%)

5/141 (3.55%)

1/64 (1.56%)

9/143 (6.29%)

1/37 (2.70%)

1/73 (1.37%)

5/116 (4.31%)

Rectal Haemorrhage * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

1/176 (0.57%)

1/103 (0.97%)

0/157 (0.00%)

0/115 (0.00%)

2/56 (3.57%)

0/141 (0.00%)

0/64 (0.00%)

2/143 (1.40%)

3/37 (8.11%)

0/73 (0.00%)

0/116 (0.00%)

Vomiting * 1

1/319 (0.31%)

3/321 (0.93%)

4/320 (1.25%)

0/184 (0.00%)

3/233 (1.29%)

5/175 (2.86%)

1/172 (0.58%)

1/176 (0.57%)

0/103 (0.00%)

3/157 (1.91%)

3/115 (2.61%)

2/56 (3.57%)

0/141 (0.00%)

1/64 (1.56%)

6/143 (4.20%)

0/37 (0.00%)

0/73 (0.00%)

2/116 (1.72%)

General disorders

Fatigue * 1

5/319 (1.57%)

6/321 (1.87%)

8/320 (2.50%)

0/184 (0.00%)

1/233 (0.43%)

4/175 (2.29%)

4/172 (2.33%)

7/176 (3.98%)

3/103 (2.91%)

3/157 (1.91%)

4/115 (3.48%)

1/56 (1.79%)

0/141 (0.00%)

2/64 (3.13%)

5/143 (3.50%)

1/37 (2.70%)

1/73 (1.37%)

2/116 (1.72%)

Influenza Like Illness * 1

2/319 (0.63%)

2/321 (0.62%)

1/320 (0.31%)

1/184 (0.54%)

1/233 (0.43%)

4/175 (2.29%)

2/172 (1.16%)

2/176 (1.14%)

0/103 (0.00%)

0/157 (0.00%)

1/115 (0.87%)

0/56 (0.00%)

2/141 (1.42%)

0/64 (0.00%)

4/143 (2.80%)

0/37 (0.00%)

1/73 (1.37%)

5/116 (4.31%)

Injection Site Erythema * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

1/184 (0.54%)

1/233 (0.43%)

1/175 (0.57%)

1/172 (0.58%)

3/176 (1.70%)

0/103 (0.00%)

3/157 (1.91%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

5/143 (3.50%)

1/37 (2.70%)

0/73 (0.00%)

3/116 (2.59%)

Injection Site Swelling * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

1/157 (0.64%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

2/37 (5.41%)

0/73 (0.00%)

0/116 (0.00%)

Pyrexia * 1

6/319 (1.88%)

4/321 (1.25%)

6/320 (1.88%)

1/184 (0.54%)

0/233 (0.00%)

7/175 (4.00%)

1/172 (0.58%)

8/176 (4.55%)

5/103 (4.85%)

5/157 (3.18%)

2/115 (1.74%)

3/56 (5.36%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

2/73 (2.74%)

7/116 (6.03%)

Hepatobiliary disorders

Hepatic Steatosis * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

1/172 (0.58%)

0/176 (0.00%)

1/103 (0.97%)

0/157 (0.00%)

1/115 (0.87%)

2/56 (3.57%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Infections and infestations

Bronchitis * 1

1/319 (0.31%)

0/321 (0.00%)

2/320 (0.63%)

1/184 (0.54%)

0/233 (0.00%)

6/175 (3.43%)

5/172 (2.91%)

6/176 (3.41%)

5/103 (4.85%)

6/157 (3.82%)

2/115 (1.74%)

3/56 (5.36%)

7/141 (4.96%)

2/64 (3.13%)

4/143 (2.80%)

0/37 (0.00%)

0/73 (0.00%)

6/116 (5.17%)

Covid-19 * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

3/143 (2.10%)

1/37 (2.70%)

0/73 (0.00%)

4/116 (3.45%)

Ear Infection * 1

0/319 (0.00%)

1/321 (0.31%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

1/172 (0.58%)

1/176 (0.57%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

1/141 (0.71%)

0/64 (0.00%)

4/143 (2.80%)

2/37 (5.41%)

0/73 (0.00%)

2/116 (1.72%)

Gastroenteritis * 1

2/319 (0.63%)

2/321 (0.62%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

5/175 (2.86%)

5/172 (2.91%)

7/176 (3.98%)

2/103 (1.94%)

5/157 (3.18%)

1/115 (0.87%)

2/56 (3.57%)

4/141 (2.84%)

0/64 (0.00%)

5/143 (3.50%)

3/37 (8.11%)

2/73 (2.74%)

8/116 (6.90%)

Herpes Zoster * 1

0/319 (0.00%)

0/321 (0.00%)

2/320 (0.63%)

1/184 (0.54%)

0/233 (0.00%)

4/175 (2.29%)

0/172 (0.00%)

2/176 (1.14%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

2/64 (3.13%)

3/143 (2.10%)

0/37 (0.00%)

0/73 (0.00%)

5/116 (4.31%)

Influenza * 1

0/319 (0.00%)

2/321 (0.62%)

1/320 (0.31%)

0/184 (0.00%)

2/233 (0.86%)

8/175 (4.57%)

5/172 (2.91%)

10/176 (5.68%)

6/103 (5.83%)

7/157 (4.46%)

4/115 (3.48%)

4/56 (7.14%)

6/141 (4.26%)

3/64 (4.69%)

10/143 (6.99%)

3/37 (8.11%)

6/73 (8.22%)

3/116 (2.59%)

Laryngitis * 1

1/319 (0.31%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

1/115 (0.87%)

2/56 (3.57%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Nasopharyngitis * 1

9/319 (2.82%)

13/321 (4.05%)

18/320 (5.63%)

7/184 (3.80%)

1/233 (0.43%)

28/175 (16.00%)

31/172 (18.02%)

26/176 (14.77%)

13/103 (12.62%)

19/157 (12.10%)

17/115 (14.78%)

13/56 (23.21%)

29/141 (20.57%)

10/64 (15.63%)

27/143 (18.88%)

12/37 (32.43%)

5/73 (6.85%)

32/116 (27.59%)

Oral Herpes * 1

5/319 (1.57%)

1/321 (0.31%)

3/320 (0.94%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

1/172 (0.58%)

3/176 (1.70%)

2/103 (1.94%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

3/141 (2.13%)

1/64 (1.56%)

6/143 (4.20%)

2/37 (5.41%)

4/73 (5.48%)

0/116 (0.00%)

Pharyngitis * 1

1/319 (0.31%)

1/321 (0.31%)

0/320 (0.00%)

1/184 (0.54%)

0/233 (0.00%)

2/175 (1.14%)

3/172 (1.74%)

2/176 (1.14%)

4/103 (3.88%)

2/157 (1.27%)

1/115 (0.87%)

0/56 (0.00%)

3/141 (2.13%)

1/64 (1.56%)

3/143 (2.10%)

2/37 (5.41%)

3/73 (4.11%)

0/116 (0.00%)

Rhinitis * 1

0/319 (0.00%)

3/321 (0.93%)

1/320 (0.31%)

1/184 (0.54%)

1/233 (0.43%)

2/175 (1.14%)

2/172 (1.16%)

4/176 (2.27%)

0/103 (0.00%)

1/157 (0.64%)

2/115 (1.74%)

2/56 (3.57%)

2/141 (1.42%)

1/64 (1.56%)

2/143 (1.40%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Sinusitis * 1

1/319 (0.31%)

5/321 (1.56%)

1/320 (0.31%)

0/184 (0.00%)

1/233 (0.43%)

2/175 (1.14%)

2/172 (1.16%)

7/176 (3.98%)

1/103 (0.97%)

3/157 (1.91%)

3/115 (2.61%)

2/56 (3.57%)

5/141 (3.55%)

1/64 (1.56%)

8/143 (5.59%)

4/37 (10.81%)

1/73 (1.37%)

4/116 (3.45%)

Tonsillitis * 1

0/319 (0.00%)

1/321 (0.31%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

2/175 (1.14%)

2/172 (1.16%)

1/176 (0.57%)

2/103 (1.94%)

0/157 (0.00%)

1/115 (0.87%)

1/56 (1.79%)

3/141 (2.13%)

0/64 (0.00%)

3/143 (2.10%)

1/37 (2.70%)

1/73 (1.37%)

6/116 (5.17%)

Upper Respiratory Tract Infection * 1

4/319 (1.25%)

6/321 (1.87%)

5/320 (1.56%)

2/184 (1.09%)

5/233 (2.15%)

8/175 (4.57%)

5/172 (2.91%)

16/176 (9.09%)

4/103 (3.88%)

7/157 (4.46%)

6/115 (5.22%)

4/56 (7.14%)

12/141 (8.51%)

4/64 (6.25%)

17/143 (11.89%)

2/37 (5.41%)

4/73 (5.48%)

10/116 (8.62%)

Urinary Tract Infection * 1

0/319 (0.00%)

3/321 (0.93%)

3/320 (0.94%)

1/184 (0.54%)

0/233 (0.00%)

4/175 (2.29%)

3/172 (1.74%)

2/176 (1.14%)

2/103 (1.94%)

4/157 (2.55%)

2/115 (1.74%)

2/56 (3.57%)

0/141 (0.00%)

3/64 (4.69%)

6/143 (4.20%)

3/37 (8.11%)

1/73 (1.37%)

3/116 (2.59%)

Viral Infection * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

2/184 (1.09%)

0/233 (0.00%)

2/175 (1.14%)

2/172 (1.16%)

3/176 (1.70%)

1/103 (0.97%)

1/157 (0.64%)

2/115 (1.74%)

0/56 (0.00%)

3/141 (2.13%)

0/64 (0.00%)

3/143 (2.10%)

2/37 (5.41%)

0/73 (0.00%)

0/116 (0.00%)

Viral Upper Respiratory Tract Infection * 1

0/319 (0.00%)

1/321 (0.31%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

2/175 (1.14%)

1/172 (0.58%)

1/176 (0.57%)

2/103 (1.94%)

1/157 (0.64%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

2/64 (3.13%)

0/143 (0.00%)

0/37 (0.00%)

1/73 (1.37%)

3/116 (2.59%)

Injury, poisoning and procedural complications

Contusion * 1

0/319 (0.00%)

1/321 (0.31%)

2/320 (0.63%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

2/172 (1.16%)

4/176 (2.27%)

0/103 (0.00%)

1/157 (0.64%)

0/115 (0.00%)

2/56 (3.57%)

1/141 (0.71%)

0/64 (0.00%)

3/143 (2.10%)

0/37 (0.00%)

0/73 (0.00%)

2/116 (1.72%)

Heat Illness * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

1/157 (0.64%)

0/115 (0.00%)

2/56 (3.57%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Ligament Sprain * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

1/103 (0.97%)

1/157 (0.64%)

1/115 (0.87%)

0/56 (0.00%)

1/141 (0.71%)

1/64 (1.56%)

0/143 (0.00%)

2/37 (5.41%)

0/73 (0.00%)

2/116 (1.72%)

Investigations

Alanine Aminotransferase Increased * 1

2/319 (0.63%)

0/321 (0.00%)

6/320 (1.88%)

0/184 (0.00%)

0/233 (0.00%)

4/175 (2.29%)

5/172 (2.91%)

6/176 (3.41%)

3/103 (2.91%)

1/157 (0.64%)

0/115 (0.00%)

7/56 (12.50%)

3/141 (2.13%)

3/64 (4.69%)

3/143 (2.10%)

1/37 (2.70%)

0/73 (0.00%)

4/116 (3.45%)

Aspartate Aminotransferase Increased * 1

2/319 (0.63%)

0/321 (0.00%)

3/320 (0.94%)

0/184 (0.00%)

0/233 (0.00%)

4/175 (2.29%)

5/172 (2.91%)

4/176 (2.27%)

4/103 (3.88%)

3/157 (1.91%)

0/115 (0.00%)

5/56 (8.93%)

1/141 (0.71%)

3/64 (4.69%)

4/143 (2.80%)

1/37 (2.70%)

0/73 (0.00%)

3/116 (2.59%)

Blood Alkaline Phosphatase Increased * 1

1/319 (0.31%)

0/321 (0.00%)

2/320 (0.63%)

0/184 (0.00%)

0/233 (0.00%)

1/175 (0.57%)

1/172 (0.58%)

1/176 (0.57%)

1/103 (0.97%)

2/157 (1.27%)

0/115 (0.00%)

2/56 (3.57%)

1/141 (0.71%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Blood Phosphorus Decreased * 1

1/319 (0.31%)

1/321 (0.31%)

1/320 (0.31%)

0/184 (0.00%)

1/233 (0.43%)

1/175 (0.57%)

1/172 (0.58%)

1/176 (0.57%)

1/103 (0.97%)

1/157 (0.64%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

2/64 (3.13%)

0/143 (0.00%)

1/37 (2.70%)

0/73 (0.00%)

0/116 (0.00%)

Stool Analysis Abnormal * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

4/56 (7.14%)

1/141 (0.71%)

1/64 (1.56%)

3/143 (2.10%)

2/37 (5.41%)

0/73 (0.00%)

1/116 (0.86%)

Metabolism and nutrition disorders

Iron Deficiency * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

1/233 (0.43%)

1/175 (0.57%)

1/172 (0.58%)

0/176 (0.00%)

1/103 (0.97%)

1/157 (0.64%)

1/115 (0.87%)

1/56 (1.79%)

1/141 (0.71%)

1/64 (1.56%)

4/143 (2.80%)

2/37 (5.41%)

0/73 (0.00%)

0/116 (0.00%)

Vitamin D Deficiency * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

1/176 (0.57%)

1/103 (0.97%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

1/141 (0.71%)

0/64 (0.00%)

5/143 (3.50%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Musculoskeletal and connective tissue disorders

Arthralgia * 1

3/319 (0.94%)

4/321 (1.25%)

6/320 (1.88%)

1/184 (0.54%)

2/233 (0.86%)

17/175 (9.71%)

16/172 (9.30%)

10/176 (5.68%)

9/103 (8.74%)

16/157 (10.19%)

6/115 (5.22%)

4/56 (7.14%)

9/141 (6.38%)

5/64 (7.81%)

11/143 (7.69%)

2/37 (5.41%)

4/73 (5.48%)

10/116 (8.62%)

Back Pain * 1

4/319 (1.25%)

2/321 (0.62%)

4/320 (1.25%)

0/184 (0.00%)

1/233 (0.43%)

7/175 (4.00%)

1/172 (0.58%)

7/176 (3.98%)

3/103 (2.91%)

5/157 (3.18%)

5/115 (4.35%)

6/56 (10.71%)

7/141 (4.96%)

3/64 (4.69%)

7/143 (4.90%)

2/37 (5.41%)

5/73 (6.85%)

6/116 (5.17%)

Nervous system disorders

Dizziness * 1

1/319 (0.31%)

2/321 (0.62%)

4/320 (1.25%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

3/176 (1.70%)

0/103 (0.00%)

2/157 (1.27%)

1/115 (0.87%)

1/56 (1.79%)

2/141 (1.42%)

2/64 (3.13%)

0/143 (0.00%)

1/37 (2.70%)

0/73 (0.00%)

1/116 (0.86%)

Headache * 1

14/319 (4.39%)

22/321 (6.85%)

13/320 (4.06%)

2/184 (1.09%)

2/233 (0.86%)

7/175 (4.00%)

11/172 (6.40%)

18/176 (10.23%)

4/103 (3.88%)

9/157 (5.73%)

7/115 (6.09%)

4/56 (7.14%)

9/141 (6.38%)

2/64 (3.13%)

11/143 (7.69%)

2/37 (5.41%)

4/73 (5.48%)

11/116 (9.48%)

Migraine * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

3/175 (1.71%)

1/172 (0.58%)

2/176 (1.14%)

0/103 (0.00%)

2/157 (1.27%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

2/64 (3.13%)

2/143 (1.40%)

0/37 (0.00%)

1/73 (1.37%)

2/116 (1.72%)

Tremor * 1

0/319 (0.00%)

1/321 (0.31%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

1/103 (0.97%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

2/37 (5.41%)

0/73 (0.00%)

0/116 (0.00%)

Psychiatric disorders

Anxiety * 1

4/319 (1.25%)

1/321 (0.31%)

0/320 (0.00%)

1/184 (0.54%)

0/233 (0.00%)

2/175 (1.14%)

3/172 (1.74%)

3/176 (1.70%)

4/103 (3.88%)

0/157 (0.00%)

0/115 (0.00%)

1/56 (1.79%)

0/141 (0.00%)

0/64 (0.00%)

2/143 (1.40%)

0/37 (0.00%)

0/73 (0.00%)

1/116 (0.86%)

Respiratory, thoracic and mediastinal disorders

Cough * 1

3/319 (0.94%)

4/321 (1.25%)

3/320 (0.94%)

0/184 (0.00%)

0/233 (0.00%)

5/175 (2.86%)

2/172 (1.16%)

7/176 (3.98%)

4/103 (3.88%)

4/157 (2.55%)

5/115 (4.35%)

5/56 (8.93%)

2/141 (1.42%)

2/64 (3.13%)

7/143 (4.90%)

1/37 (2.70%)

1/73 (1.37%)

4/116 (3.45%)

Oropharyngeal Pain * 1

1/319 (0.31%)

1/321 (0.31%)

8/320 (2.50%)

1/184 (0.54%)

0/233 (0.00%)

5/175 (2.86%)

4/172 (2.33%)

7/176 (3.98%)

1/103 (0.97%)

1/157 (0.64%)

0/115 (0.00%)

1/56 (1.79%)

7/141 (4.96%)

0/64 (0.00%)

5/143 (3.50%)

0/37 (0.00%)

1/73 (1.37%)

3/116 (2.59%)

Skin and subcutaneous tissue disorders

Acne * 1

3/319 (0.94%)

1/321 (0.31%)

2/320 (0.63%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

2/172 (1.16%)

3/176 (1.70%)

4/103 (3.88%)

0/157 (0.00%)

0/115 (0.00%)

0/56 (0.00%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

1/37 (2.70%)

0/73 (0.00%)

0/116 (0.00%)

Eczema * 1

5/319 (1.57%)

1/321 (0.31%)

2/320 (0.63%)

0/184 (0.00%)

1/233 (0.43%)

5/175 (2.86%)

0/172 (0.00%)

3/176 (1.70%)

2/103 (1.94%)

0/157 (0.00%)

0/115 (0.00%)

2/56 (3.57%)

1/141 (0.71%)

0/64 (0.00%)

2/143 (1.40%)

1/37 (2.70%)

0/73 (0.00%)

3/116 (2.59%)

Papule * 1

0/319 (0.00%)

0/321 (0.00%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

2/175 (1.14%)

0/172 (0.00%)

0/176 (0.00%)

1/103 (0.97%)

0/157 (0.00%)

0/115 (0.00%)

2/56 (3.57%)

0/141 (0.00%)

0/64 (0.00%)

0/143 (0.00%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Pruritus * 1

4/319 (1.25%)

8/321 (2.49%)

3/320 (0.94%)

1/184 (0.54%)

0/233 (0.00%)

4/175 (2.29%)

1/172 (0.58%)

2/176 (1.14%)

3/103 (2.91%)

2/157 (1.27%)

1/115 (0.87%)

1/56 (1.79%)

1/141 (0.71%)

2/64 (3.13%)

2/143 (1.40%)

0/37 (0.00%)

0/73 (0.00%)

3/116 (2.59%)

Rash * 1

1/319 (0.31%)

3/321 (0.93%)

4/320 (1.25%)

1/184 (0.54%)

2/233 (0.86%)

6/175 (3.43%)

6/172 (3.49%)

6/176 (3.41%)

2/103 (1.94%)

2/157 (1.27%)

0/115 (0.00%)

1/56 (1.79%)

2/141 (1.42%)

1/64 (1.56%)

5/143 (3.50%)

1/37 (2.70%)

6/73 (8.22%)

3/116 (2.59%)

Skin Lesion * 1

0/319 (0.00%)

0/321 (0.00%)

1/320 (0.31%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

0/172 (0.00%)

0/176 (0.00%)

0/103 (0.00%)

0/157 (0.00%)

0/115 (0.00%)

2/56 (3.57%)

0/141 (0.00%)

0/64 (0.00%)

1/143 (0.70%)

0/37 (0.00%)

0/73 (0.00%)

0/116 (0.00%)

Vascular disorders

Hypertension * 1

5/319 (1.57%)

1/321 (0.31%)

0/320 (0.00%)

0/184 (0.00%)

0/233 (0.00%)

0/175 (0.00%)

4/172 (2.33%)

3/176 (1.70%)

1/103 (0.97%)

3/157 (1.91%)

1/115 (0.87%)

2/56 (3.57%)

5/141 (3.55%)

1/64 (1.56%)

5/143 (3.50%)

3/37 (8.11%)

3/73 (4.11%)

3/116 (2.59%)

1 Term from vocabulary, MedDRA Version 24.1; * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.

Results Point of Contact

• Name/Title: Senior Director Clinical Development
• Organization: Janssen Research & Development, LLC
• Phone: 844-434-4210
• EMail: ClinicalTrialDisclosure@its.jnj.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Danese S, Sands BE, Abreu MT, O'Brien CD, Bravata I, Nazar M, Miao Y, Wang Y, Rowbotham D, Leong RWL, Arasaradnam RP, Afif W, Marano C. Early Symptomatic Improvement After Ustekinumab Therapy in Patients With Ulcerative Colitis: 16-Week Data From the UNIFI Trial. Clin Gastroenterol Hepatol. 2022 Dec;20(12):2858-2867.e5. doi: 10.1016/j.cgh.2022.02.050. Epub 2022 Mar 8.

Panaccione R, Danese S, Sandborn WJ, O'Brien CD, Zhou Y, Zhang H, Adedokun OJ, Tikhonov I, Targan S, Abreu MT, Hisamatsu T, Scherl EJ, Leong RW, Rowbotham DS, Arasaradnam RP, Sands BE, Marano C. Ustekinumab is effective and safe for ulcerative colitis through 2 years of maintenance therapy. Aliment Pharmacol Ther. 2020 Dec;52(11-12):1658-1675. doi: 10.1111/apt.16119. Epub 2020 Oct 21. Erratum In: Aliment Pharmacol Ther. 2021 May;53(9):1057-1060. Aliment Pharmacol Ther. 2021 Nov;54(9):1221-1222.

Sandborn WJ, Feagan BG, Danese S, O'Brien CD, Ott E, Marano C, Baker T, Zhou Y, Volger S, Tikhonov I, Gasink C, Sands BE, Ghosh S. Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis of Results from Phase 2/3 Studies. Inflamm Bowel Dis. 2021 Jun 15;27(7):994-1007. doi: 10.1093/ibd/izaa236. Erratum In: Inflamm Bowel Dis. 2021 Jun 15;27(7):1175.

Li K, Marano C, Zhang H, Yang F, Sandborn WJ, Sands BE, Feagan BG, Rubin DT, Peyrin-Biroulet L, Friedman JR, De Hertogh G. Relationship Between Combined Histologic and Endoscopic Endpoints and Efficacy of Ustekinumab Treatment in Patients With Ulcerative Colitis. Gastroenterology. 2020 Dec;159(6):2052-2064. doi: 10.1053/j.gastro.2020.08.037. Epub 2020 Aug 25.

Sands BE, Sandborn WJ, Panaccione R, O'Brien CD, Zhang H, Johanns J, Adedokun OJ, Li K, Peyrin-Biroulet L, Van Assche G, Danese S, Targan S, Abreu MT, Hisamatsu T, Szapary P, Marano C; UNIFI Study Group. Ustekinumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2019 Sep 26;381(13):1201-1214. doi: 10.1056/NEJMoa1900750.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT02407236
• Other Study ID Numbers: CR106920; 2014-005606-38 ( EudraCT Number ); CNTO1275UCO3001 ( Other Identifier: Janssen Research & Development, LLC )
• First Submitted: March 30, 2015
• First Posted: April 2, 2015
• Results First Submitted: November 15, 2019
• Results First Posted: December 23, 2019
• Last Update Posted: January 5, 2023