Dose-escalation Study of Combination BMS-936558 (MDX-1106) and Ipilimumab in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma

• ClinicalTrials.gov Identifier: NCT01024231
• Recruitment Status: Completed
• First Posted: December 2, 2009
• Results First Posted: March 22, 2021
• Last Update Posted: March 22, 2021
• Sponsor: Bristol-Myers Squibb
• Collaborators: Medarex; Ono Pharma USA Inc
• Information provided by (Responsible Party): Bristol-Myers Squibb

• Study Type: Interventional
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Malignant Melanoma
• Interventions: Drug: BMS-936558 (MDX1106-04); Drug: Ipilimumab
• Enrollment: 127

Participant Flow

Recruitment Details
Pre-assignment Details	127 Randomized and Treated

Arm/Group Title	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Cohort 6	Cohorot 7	Cohort 8
Arm/Group Description	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses
Period Title: Overall Study
Started	14	17	16	6	17	16	41
Completed	2	2	6	1	0	0	20
Not Completed	12	15	10	5	17	16	21
Reason Not Completed
Other Reasons	1	2	0	0	2	0	1
Maximum Clinical Benefit	1	2	0	1	1	0	0
Disease Progression	3	1	3	0	4	11	6
AE unrelated to Study Drug	0	1	0	0	0	0	0
No longer meets criteria	0	0	0	0	1	0	1
Study Drug Toxicity	1	6	6	4	2	0	7
Death	6	2	1	0	4	3	5
Lost to Follow-up	0	0	0	0	0	0	1
Withdrew Consent	0	1	0	0	0	0	0
Continuing on Treatment	0	0	0	0	3	2	0

Baseline Characteristics

Arm/Group Title		Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Cohort 6	Cohorot 7	Cohort 8	Total
Arm/Group Description		0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	Total of all reporting groups
Overall Number of Baseline Participants		14	17	16	6	17	16	41	127
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	14 participants	17 participants	16 participants	6 participants	17 participants	16 participants	41 participants	127 participants
		57.9 (9.58)	53.5 (14.14)	59.1 (14.65)	56.2 (11.99)	63.9 (14.37)	60.6 (17.56)	55.2 (15.83)	57.6 (13.78)
Age, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	14 participants	17 participants	16 participants	6 participants	17 participants	16 participants	41 participants	127 participants
<65 Years		11 78.6%	14 82.4%	10 62.5%	5 83.3%	7 41.2%	11 68.8%	32 78.0%	90 70.9%
≥ 65 Years		3 21.4%	3 17.6%	6 37.5%	1 16.7%	10 58.8%	5 31.3%	9 22.0%	37 29.1%
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	14 participants	17 participants	16 participants	6 participants	17 participants	16 participants	41 participants	127 participants
	Female	5 35.7%	7 41.2%	4 25.0%	5 83.3%	8 47.1%	7 43.8%	23 56.1%	59 46.5%
	Male	9 64.3%	10 58.8%	12 75.0%	1 16.7%	9 52.9%	9 56.3%	18 43.9%	68 53.5%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	14 participants	17 participants	16 participants	6 participants	17 participants	16 participants	41 participants	127 participants
	Hispanic or Latino	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 5.9%	0 0.0%	2 4.9%	3 2.4%
	Not Hispanic or Latino	14 100.0%	17 100.0%	16 100.0%	6 100.0%	15 88.2%	16 100.0%	39 95.1%	123 96.9%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 5.9%	0 0.0%	0 0.0%	1 0.8%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	14 participants	17 participants	16 participants	6 participants	17 participants	16 participants	41 participants	127 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.4%	1 0.8%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 5.9%	0 0.0%	0 0.0%	1 0.8%
	White	14 100.0%	17 100.0%	16 100.0%	6 100.0%	16 94.1%	16 100.0%	37 90.2%	122 96.1%
	More than one race	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	3 7.3%	3 2.4%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With an Adverse Event (AE)
Description	incidence of all cause and treatment related adverse events
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Any BMS and Ipi Combo	Cohort 6	Cohorot 7	Only BMS	Cohort 8	Any BMS/Ipi	Total
Arm/Group Description:	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	All participants who received treatment in Cohorts 1 through 3	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	combined total of participants who receive BMS only	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	All participants who received both BMS and Ipi	All Participants who received treatment in any cohort combined
Overall Number of Participants Analyzed	14	17	16	6	53	17	16	33	41	94	127
Measure Type: Count of Participants; Unit of Measure: Participants
All Cause	14 100.0%	17 100.0%	16 100.0%	6 100.0%	53 100.0%	17 100.0%	16 100.0%	33 100.0%	41 100.0%	94 100.0%	127 100.0%
Treatment Related	13 92.9%	17 100.0%	15 93.8%	6 100.0%	51 96.2%	15 88.2%	13 81.3%	28 84.8%	40 97.6%	91 96.8%	119 93.7%

2. Primary Outcome

Title	Number of Participants With a Serious Adverse Event (AE)
Description	incidence of all cause and treatment related serious adverse events
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Any BMS and Ipi Combo	Cohort 6	Cohorot 7	Only BMS	Cohort 8	Any BMS/Ipi	Total
Arm/Group Description:	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	All participants who received treatment in Cohorts 1 through 3	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	combined total of participants who receive BMS only	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	All participants who received both BMS and Ipi	All Participants who received treatment in any cohort combined
Overall Number of Participants Analyzed	14	17	16	6	53	17	16	33	41	94	127
Measure Type: Count of Participants; Unit of Measure: Participants
All Cause	10 71.4%	15 88.2%	10 62.5%	5 83.3%	40 75.5%	9 52.9%	10 62.5%	19 57.6%	26 63.4%	66 70.2%	85 66.9%
Treatment Related	5 35.7%	13 76.5%	9 56.3%	4 66.7%	31 58.5%	4 23.5%	4 25.0%	8 24.2%	18 43.9%	49 52.1%	57 44.9%

3. Primary Outcome

Title	Number of Participants With an Adverse Event (AE) Which Lead to Discontinuation
Description	incidence of all cause and treatment related adverse events which lead to discontinuation
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Any BMS and Ipi Combo	Cohort 6	Cohorot 7	Only BMS	Cohort 8	Any BMS/Ipi	Total
Arm/Group Description:	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	All participants who received treatment in Cohorts 1 through 3	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	combined total of participants who receive BMS only	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	All participants who received both BMS and Ipi	All Participants who received treatment in any cohort combined
Overall Number of Participants Analyzed	14	17	16	6	53	17	16	33	41	94	127
Measure Type: Count of Participants; Unit of Measure: Participants
All Cause	2 14.3%	8 47.1%	5 31.3%	1 16.7%	16 30.2%	5 29.4%	1 6.3%	6 18.2%	13 31.7%	29 30.9%	35 27.6%
Treatment Related	2 14.3%	6 35.3%	5 31.3%	1 16.7%	14 26.4%	2 11.8%	0 0.0%	2 6.1%	11 26.8%	25 26.6%	27 21.3%

4. Primary Outcome

Title	Number of Deaths
Description	incidence of all cause and treatment related deaths
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Any BMS and Ipi Combo	Cohort 6	Cohorot 7	Only BMS	Cohort 8	Any BMS/Ipi	Total
Arm/Group Description:	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	All participants who received treatment in Cohorts 1 through 3	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	combined total of participants who receive BMS only	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	All participants who received both BMS and Ipi	All Participants who received treatment in any cohort combined
Overall Number of Participants Analyzed	14	17	16	6	53	17	16	33	41	94	127
Measure Type: Count of Participants; Unit of Measure: Participants
All Cause	8 57.1%	4 23.5%	2 12.5%	0 0.0%	14 26.4%	7 41.2%	8 50.0%	15 45.5%	8 19.5%	22 23.4%	37 29.1%
Treatment Related	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.4%	1 1.1%	1 0.8%

5. Primary Outcome

Title	Number of Participants With Select AEs
Description	incidence of all cause and treatment related Adverse events in certain organ systems
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Any BMS and Ipi Combo	Cohort 6	Cohorot 7	Only BMS	Cohort 8	Any BMS/Ipi	Total
Arm/Group Description:	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	All participants who received treatment in Cohorts 1 through 3	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	combined total of participants who receive BMS only	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	All participants who received both BMS and Ipi	All Participants who received treatment in any cohort combined
Overall Number of Participants Analyzed	14	17	16	6	53	17	16	33	41	94	127
Measure Type: Count of Participants; Unit of Measure: Participants
Endrocrine	2 14.3%	5 29.4%	3 18.8%	3 50.0%	13 24.5%	4 23.5%	1 6.3%	5 15.2%	12 29.3%	25 26.6%	30 23.6%
Gastrointestinal	5 35.7%	7 41.2%	10 62.5%	4 66.7%	26 49.1%	3 17.6%	4 25.0%	7 21.2%	20 48.8%	46 48.9%	53 41.7%
Hepatic	5 35.7%	6 35.3%	4 25.0%	3 50.0%	18 34.0%	1 5.9%	1 6.3%	2 6.1%	8 19.5%	26 27.7%	28 22.0%
Pulmonary	1 7.1%	2 11.8%	1 6.3%	0 0.0%	4 7.5%	0 0.0%	1 6.3%	1 3.0%	2 4.9%	6 6.4%	7 5.5%
Renal	2 14.3%	1 5.9%	1 6.3%	1 16.7%	5 9.4%	0 0.0%	1 6.3%	1 3.0%	1 2.4%	6 6.4%	7 5.5%
Skin	12 85.7%	15 88.2%	15 93.8%	4 66.7%	46 86.8%	8 47.1%	10 62.5%	18 54.5%	34 82.9%	80 85.1%	98 77.2%
Hypersensitivity/Infusion Reaction	0 0.0%	1 5.9%	1 6.3%	0 0.0%	2 3.8%	1 5.9%	1 6.3%	2 6.1%	1 2.4%	3 3.2%	5 3.9%

6. Primary Outcome

Title	Laboratory Abnormalities: Specific Liver Tests
Description	Number of Participants with On-Treatment Laboratory Abnormalities in Specific Liver Tests Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN)
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Any BMS and Ipi Combo	Cohort 6	Cohorot 7	Only BMS	Cohort 8	Any BMS/Ipi	Total
Arm/Group Description:	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	All participants who received treatment in Cohorts 1 through 3	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	combined total of participants who receive BMS only	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	All participants who received both BMS and Ipi	All Participants who received treatment in any cohort combined
Overall Number of Participants Analyzed	14	17	16	6	53	17	16	33	41	94	127
Measure Type: Count of Participants; Unit of Measure: Participants
ALT or AST > 3xULN	1 7.1%	0 0.0%	2 12.5%	3 50.0%	6 11.3%	0 0.0%	1 6.3%	1 3.0%	6 14.6%	12 12.8%	13 10.2%
ALT or AST > 5xULN	3 21.4%	1 5.9%	1 6.3%	1 16.7%	6 11.3%	0 0.0%	0 0.0%	0 0.0%	5 12.2%	11 11.7%	11 8.7%
ALT or AST > 10xULN	0 0.0%	0 0.0%	0 0.0%	1 16.7%	1 1.9%	0 0.0%	0 0.0%	0 0.0%	4 9.8%	5 5.3%	5 3.9%
ALT or AST > 20xULN	1 7.1%	0 0.0%	0 0.0%	0 0.0%	1 1.9%	0 0.0%	0 0.0%	0 0.0%	3 7.3%	4 4.3%	4 3.1%
Total Bilirubin (Tbili) > 2xULN	1 7.1%	0 0.0%	0 0.0%	0 0.0%	1 1.9%	0 0.0%	0 0.0%	0 0.0%	2 4.9%	3 3.2%	3 2.4%
ALT or AST > 3xULN w/ Tbili > 2xULN within 1 day	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	1 2.4%	1 1.1%	1 0.8%

7. Primary Outcome

Title	Laboratory Abnormalities: Specific Thyroid Tests
Description	Number of Participants with On-Treatment Laboratory Abnormalities in Specific Thyroid Tests Free T3 (FT3) Free T4 (FT4) Lower Limit of Normal (LLN)
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Any BMS and Ipi Combo	Cohort 6	Cohorot 7	Only BMS	Cohort 8	Any BMS/Ipi	Total
Arm/Group Description:	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	All participants who received treatment in Cohorts 1 through 3	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	combined total of participants who receive BMS only	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	All participants who received both BMS and Ipi	All Participants who received treatment in any cohort combined
Overall Number of Participants Analyzed	14	17	16	6	53	17	16	33	41	94	127
Measure Type: Count of Participants; Unit of Measure: Participants
TSH > ULN	7 50.0%	9 52.9%	7 43.8%	3 50.0%	26 49.1%	4 23.5%	3 18.8%	7 21.2%	8 19.5%	34 36.2%	41 32.3%
TSH > ULN with TSH≤ ULN @ Baseline	3 21.4%	6 35.3%	7 43.8%	1 16.7%	17 32.1%	3 17.6%	1 6.3%	4 12.1%	6 14.6%	23 24.5%	27 21.3%
TSH > ULN: WITH ALL OTHER T3/T4 TEST ≥ LLN	7 50.0%	9 52.9%	7 43.8%	2 33.3%	25 47.2%	4 23.5%	3 18.8%	7 21.2%	8 19.5%	33 35.1%	40 31.5%
TSH > ULN: WITH AT LEAST ONE T3/T4 TEST < LLN	5 35.7%	6 35.3%	5 31.3%	2 33.3%	18 34.0%	2 11.8%	1 6.3%	3 9.1%	5 12.2%	23 24.5%	26 20.5%
TSH > ULN: WITH FT3/FT4 TEST MISSING	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
TSH < LLN	3 21.4%	7 41.2%	7 43.8%	3 50.0%	20 37.7%	4 23.5%	1 6.3%	5 15.2%	14 34.1%	34 36.2%	39 30.7%
TSH < LLN: WITH TSH >= LLN AT BASELINE	3 21.4%	7 41.2%	7 43.8%	3 50.0%	20 37.7%	3 17.6%	0 0.0%	3 9.1%	14 34.1%	34 36.2%	37 29.1%
TSH < LLN: WITH ALL OTHER FT3/FT4 TEST ≤ ULN	2 14.3%	6 35.3%	6 37.5%	3 50.0%	17 32.1%	4 23.5%	1 6.3%	5 15.2%	11 26.8%	28 29.8%	33 26.0%
TSH < LLN: WITH AT LEAST ONE T3/T4 TEST > ULN	3 21.4%	3 17.6%	3 18.8%	2 33.3%	11 20.8%	2 11.8%	0 0.0%	2 6.1%	8 19.5%	19 20.2%	21 16.5%
TSH < LLN: WITH FT3/FT4 TEST MISSING	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%

8. Secondary Outcome

Title	Objective Response Rate
Description	the total number of participants whose best overall response (BOR) is either irCR or irPR divided by the total number of response-evaluable participants.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Any BMS and Ipi Combo	Cohort 6	Cohorot 7	Only BMS	Cohort 8	Any BMS/Ipi	Total
Arm/Group Description:	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	All participants who received treatment in Cohorts 1 through 3	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	combined total of participants who receive BMS only	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	All participants who received both BMS and Ipi	All Participants who received treatment in any cohort combined
Overall Number of Participants Analyzed	14	17	16	6	53	17	16	33	41	94	127
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of Participants
	21; (4.7 to 50.8)	47; (23.0 to 72.2)	50; (24.7 to 75.3)	50; (11.8 to 88.2)	42; (28.1 to 55.9)	53; (27.8 to 77.0)	19; (4.0 to 45.6)	36; (20.4 to 54.9)	44; (28.5 to 60.3)	43; (32.4 to 53.2)	41; (32.3 to 50.0)

9. Secondary Outcome

Title	Time to Response
Description	the time from the first dose of study drug until the first documentation of irCR or irPR, as related to current database lock date or most current tumor measurement
Time Frame	Up to 3 Years

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Any BMS and Ipi Combo	Cohort 6	Cohorot 7	Only BMS	Cohort 8	Any BMS/Ipi	Total
Arm/Group Description:	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	All participants who received treatment in Cohorts 1 through 3	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	combined total of participants who receive BMS only	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	All participants who received both BMS and Ipi	All Participants who received treatment in any cohort combined
Overall Number of Participants Analyzed	14	17	16	6	53	17	16	33	41	94	127
Median (Full Range); Unit of Measure: Weeks
	11.9; (11.9 to 12.9)	11.9; (7.7 to 14.7)	11.9; (7.0 to 18.7)	12.3; (10.4 to 18.0)	11.9; (7.0 to 18.7)	8; (7.4 to 34.1)	15.7; (7.7 to 16.0)	9.6; (7.4 to 34.1)	12.1; (11.0 to 24.1)	12; (7.0 to 24.1)	12; (7.0 to 34.1)

10. Secondary Outcome

Title	Duration of Response
Description	the time from the first documented response (irCR or irPR) until progression or death, whichever occurs first. For participants who did not progress or die, duration of response will be censored on the date of the last tumor assessment.
Time Frame	from the first documented response (irCR or irPR) until progression or death

Outcome Measure Data

Analysis Population Description

All Treated Participants with a response

Arm/Group Title	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Any BMS and Ipi Combo	Cohort 6	Cohorot 7	Only BMS	Cohort 8	Any BMS/Ipi	Total
Arm/Group Description:	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	All participants who received treatment in Cohorts 1 through 3	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	combined total of participants who receive BMS only	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	All participants who received both BMS and Ipi	All Participants who received treatment in any cohort combined
Overall Number of Participants Analyzed	14	17	16	6	53	17	3	33	41	94	127
Median (95% Confidence Interval); Unit of Measure: Weeks
	NA [1]; (78.4 to NA)	105; (105 to 141)	66.3 [2]; (66.3 to NA)	59.1; (31.3 to 86.9)	105; (86.9 to 141)	73.1 [3]; (73.1 to NA)	64.3 [4]; (NA to NA)	73.1 [2]; (64.3 to NA)	NA [5]; (NA to NA)	105; (78.4 to 141)	105; (78.4 to 141)

[1]

Not a sufficient amount of responders to calculate median duration of response.

[2]

insufficient number of responders in order to derive 95%CI

[3]

upper limit number not reached

[4]

upper limit number not reached

lower limit number: insufficient number of responders in order to derive 95%CI

[5]

Not a sufficient amount of responders to calculate median duration of response.

lower limit number: insufficient number of responders in order to derive 95%CI

11. Secondary Outcome

Title	Progression Free Survival
Description	the time from the first dose to the first observation of disease progression or death due to any cause. If a participant has not progressed or died at the time of analysis, PFS will be censored on the date of the last disease assessment. Participants who did not have any on-study tumor assessments and did not die will be censored on the date of the first dose of study medication.
Time Frame	156 weeks

Outcome Measure Data

Analysis Population Description

All Treated Participants

Arm/Group Title	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Any BMS and Ipi Combo	Cohort 6	Cohorot 7	Only BMS	Cohort 8	Any BMS/Ipi
Arm/Group Description:	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	All participants who received treatment in Cohorts 1 through 3	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	Combined total of participants who receive BMS only	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	All participants who received both BMS and Ipi
Overall Number of Participants Analyzed	14	17	16	6	0	17	16	0	41	0
Median (95% Confidence Interval); Unit of Measure: Weeks
	12.50; (11.60 to 47.90)	64.40; (12.00 to 149.00)	58.40 [1]; (12.00 to NA)	33.55; (11.60 to 97.10)		24.60 [1]; (8.10 to NA)	12.15; (7.70 to 23.90)		37.10 [1]; (12.90 to NA)

[1]

Upper limit number not reached

12. Secondary Outcome

Title	Number of Participants With an Anti-Drug Antibody (ADA) Response for Nivolumab (Nivo) and Ipilimumab (Ipi)
Description	Serum samples will be collected to evaluate the development of antibodies to BMS-936558 and to ipilimumab.
Time Frame	Up to 3 years

Outcome Measure Data

Analysis Population Description

All Treated Participants with baseline and at least one post baseline assessment

Arm/Group Title		Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Any BMS and Ipi Combo	Cohort 6	Cohorot 7	Only BMS	Cohort 8	Any BMS/Ipi	Total
Arm/Group Description:		0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	All participants who received treatment in Cohorts 1 through 3	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	combined total of participants who receive BMS only	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	All participants who received both BMS and Ipi	All Participants who received treatment in any cohort combined
Overall Number of Participants Analyzed		13	17	16	5	51	15	12	27	35	86	113
Measure Type: Count of Participants; Unit of Measure: Participants
Baseline ADA Positive (nivo)	Number Analyzed	13 participants	17 participants	16 participants	5 participants	51 participants	15 participants	12 participants	27 participants	35 participants	86 participants	113 participants
		1 7.7%	1 5.9%	2 12.5%	0 0.0%	4 7.8%	1 6.7%	0 0.0%	1 3.7%	1 2.9%	5 5.8%	6 5.3%
Baseline ADA Positive (ipi)	Number Analyzed	13 participants	17 participants	16 participants	5 participants	51 participants	14 participants	11 participants	25 participants	32 participants	83 participants	108 participants
		0 0.0%	1 5.9%	0 0.0%	1 20.0%	2 3.9%	0 0.0%	0 0.0%	0 0.0%	1 3.1%	3 3.6%	3 2.8%
ADA Positive (nivo)	Number Analyzed	13 participants	17 participants	16 participants	5 participants	51 participants	15 participants	12 participants	27 participants	35 participants	86 participants	113 participants
		6 46.2%	10 58.8%	4 25.0%	0 0.0%	20 39.2%	4 26.7%	1 8.3%	5 18.5%	10 28.6%	30 34.9%	35 31.0%
ADA Positive (ipi)	Number Analyzed	13 participants	17 participants	16 participants	5 participants	51 participants	14 participants	11 participants	25 participants	32 participants	83 participants	108 participants
		1 7.7%	0 0.0%	0 0.0%	0 0.0%	1 2.0%	1 7.1%	1 9.1%	2 8.0%	1 3.1%	2 2.4%	4 3.7%
ADA Negative (nivo)	Number Analyzed	13 participants	17 participants	16 participants	5 participants	51 participants	15 participants	12 participants	27 participants	35 participants	86 participants	113 participants
		7 53.8%	7 41.2%	12 75.0%	5 100.0%	31 60.8%	11 73.3%	11 91.7%	22 81.5%	25 71.4%	56 65.1%	78 69.0%
ADA Negative (ipi)	Number Analyzed	13 participants	17 participants	16 participants	5 participants	51 participants	14 participants	11 participants	25 participants	32 participants	83 participants	108 participants
		12 92.3%	17 100.0%	16 100.0%	5 100.0%	50 98.0%	13 92.9%	10 90.9%	23 92.0%	31 96.9%	81 97.6%	104 96.3%

13. Secondary Outcome

Title	Peak and Trough Concentrations
Description	The peak and trough concentrations of BMS-936558 (MDX-1106) and ipilimumab in participants with quantifiable data
Time Frame	Up to 64 Weeks

Outcome Measure Data

Analysis Population Description

All Treated Participants with quantifiable data

Arm/Group Title		Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Any BMS and Ipi Combo	Cohort 6	Cohorot 7	Only BMS	Cohort 8	Any BMS/Ipi	Total
Arm/Group Description:		0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	All participants who received treatment in Cohorts 1 through 3	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	combined total of participants who receive BMS only	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses	All participants who received both BMS and Ipi	All Participants who received treatment in any cohort combined
Overall Number of Participants Analyzed		14	17	16	6	0	7	10	0	40	0	0
Geometric Mean (Geometric Coefficient of Variation); Unit of Measure: ug/mL
Nivo Peak (Cmax)	Number Analyzed	13 participants	17 participants	15 participants	6 participants	0 participants	7 participants	10 participants	0 participants	40 participants	0 participants	0 participants
		6.5; (17.2%)	21.5; (17.9%)	49.8; (24.7%)	63.4; (18.0%)		20.5; (64.5%)	97.7; (52.5%)		18.1; (38.1%)
Nivo Trough (Cmin)	Number Analyzed	5 participants	11 participants	9 participants	3 participants	0 participants	6 participants	10 participants	0 participants	13 participants	0 participants	0 participants
		1.5; (44.9%)	2.6; (94.4%)	27.7; (23.9%)	23.9; (37.5%)		13.2; (40.9%)	53.1; (49.8%)		5.9; (49.3%)
Ipi Peak (Cmax)	Number Analyzed	13 participants	17 participants	16 participants	6 participants	0 participants	0 participants	0 participants	0 participants	36 participants	0 participants	0 participants
		63.9; (17.7%)	68.5; (20.4%)	19.8; (40.6%)	63.2; (24.2%)					63.5; (31.5%)
Ipi Trough (Cmin)	Number Analyzed	14 participants	14 participants	15 participants	4 participants	0 participants	0 participants	0 participants	0 participants	33 participants	0 participants	0 participants
		9.7; (33.7%)	11.9; (29.5%)	3.6; (30.4%)	9.2; (34.4%)					9.8; (43.7%)

Adverse Events

Time Frame	Within 100 days of discontinuation of dosing or within 30 days of the last visit for screen failures (Approximately 3 years)
Adverse Event Reporting Description	The Following arms: Any BMS and Ipi Combo, Only BMS and Total, were left out of the AE section because the participants in those arms are reflected in the other arms.
Arm/Group Title	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Cohort 6	Cohorot 7	Cohort 8
Arm/Group Description	0.3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 1 mg/kg of ipilimumab	3 mg/kg of BMS-936558 (MDX-1106) + 3 mg/kg of ipilimumab	1mg/kg of BMS-936558 (MDX-1106)	3 mg/kg of BMS-936558 (MDX-1106)	1 mg/kg of BMS-936558 (MDX-1106) in combination with 3 mg/kg of ipilimumab every 3 weeks for 4 doses
All-Cause Mortality
	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Cohort 6	Cohorot 7	Cohort 8
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	8/14 (57.14%)	4/17 (23.53%)	2/16 (12.50%)	0/6 (0.00%)	7/17 (41.18%)	8/16 (50.00%)	8/41 (19.51%)
Serious Adverse Events
	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Cohort 6	Cohorot 7	Cohort 8
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	10/14 (71.43%)	15/17 (88.24%)	10/16 (62.50%)	5/6 (83.33%)	9/17 (52.94%)	10/16 (62.50%)	26/41 (63.41%)
Blood and lymphatic system disorders
Anemia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Hemolysis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Cardiac disorders
Supraventricular Tachycardia † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Tachycardia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Atrial Fibrillation † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	1/41 (2.44%)
Endocrine disorders
Adrenal Insufficiency † 1	0/14 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	1/41 (2.44%)
Hyperthyroidism † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Hypothyroidism † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Thyroiditis † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Hypophysitis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	1/17 (5.88%)	1/16 (6.25%)	1/41 (2.44%)
Eye disorders
Uveitis † 1	0/14 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Vision Blurred † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Dry Eye † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Gastrointestinal disorders
Vomiting † 1	2/14 (14.29%)	3/17 (17.65%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	2/41 (4.88%)
Colitis † 1	1/14 (7.14%)	2/17 (11.76%)	2/16 (12.50%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	4/41 (9.76%)
Nausea † 1	1/14 (7.14%)	2/17 (11.76%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Pancreatitis † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Abdominal Pain † 1	0/14 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	2/41 (4.88%)
Appendix Disorders † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Constipation † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Small Intestinal Obstruction † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	2/16 (12.50%)	1/41 (2.44%)
Diverticular Perforation † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Diarrhea † 1	0/14 (0.00%)	2/17 (11.76%)	3/16 (18.75%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	7/41 (17.07%)
Gastrointestinal Pain † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Ascites † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Enterocolitis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
General disorders
Pain † 1	2/14 (14.29%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Asthenia † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Disease Progression † 1	1/14 (7.14%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	2/16 (12.50%)	2/41 (4.88%)
Pyrexia † 1	1/14 (7.14%)	1/17 (5.88%)	2/16 (12.50%)	1/6 (16.67%)	1/17 (5.88%)	1/16 (6.25%)	2/41 (4.88%)
Death † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	2/41 (4.88%)
Sudden Death † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Chest Pain † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Multiorgan Failure † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Edema Peripheral † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Fatigue † 1	0/14 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Hepatobiliary disorders
Cholecystitis Acute † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Hyperbilirubinemia † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Acute Cholecystitis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Immune system disorders
Autoimmune Disorder † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Infections and infestations
Superinfection † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Urinary Tract Infections † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Chorioretinitis † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Viral Infection † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Device Related Infection † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Sepsis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Enterococcal Sepsis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Infection † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	2/41 (4.88%)
Diverticulitis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Pneumonia † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	1/41 (2.44%)
Pneumonitis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Investigations
Alanine Aminotransferase Increased † 1	3/14 (21.43%)	3/17 (17.65%)	2/16 (12.50%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	2/41 (4.88%)
Aspartate Aminotransferase Increased † 1	3/14 (21.43%)	3/17 (17.65%)	2/16 (12.50%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	2/41 (4.88%)
Blood Creatinine Increased † 1	2/14 (14.29%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Amylase Increased † 1	0/14 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	1/6 (16.67%)	1/17 (5.88%)	2/16 (12.50%)	0/41 (0.00%)
Lipase Increased † 1	0/14 (0.00%)	1/17 (5.88%)	2/16 (12.50%)	1/6 (16.67%)	1/17 (5.88%)	2/16 (12.50%)	0/41 (0.00%)
Blood Urea Increased † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Troponin 1 Increased † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Blood Alkaline Phosphatase Increased † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Troponin T Increased † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Metabolism and nutrition disorders
Dehydration † 1	1/14 (7.14%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Decreased Appetite † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Hypokalemia † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Hyponatremia † 1	0/14 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Failure to Thrive † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Hyperuricemia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Musculoskeletal and connective tissue disorders
Pain in Extremity † 1	1/14 (7.14%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Muscular Weakness † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Neck Pain † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Arthralgia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Back Pain † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	0/41 (0.00%)
Bone Lesion † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Brain Neoplasm † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Metastasis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Metastasis to Central Nervous System † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Nervous system disorders
Convulsions † 1	1/14 (7.14%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Dizziness † 1	0/14 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Headache † 1	0/14 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	2/41 (4.88%)
Central Nervous System Necrosis † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Cerebral Ischemia † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Cognitive Disorders † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Syncope † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Aphasia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Dysarthria † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Hemorrhage † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Central Nervous System Hemorrhage † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Psychiatric disorders
Confusional State † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Mental Status Changes † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Renal and urinary disorders
Tubulointerstitial Nephritis † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Renal Failure Acute † 1	0/14 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Urinary Tract Infection † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Urinary Tract Obstruction † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnea † 1	2/14 (14.29%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	1/17 (5.88%)	0/16 (0.00%)	2/41 (4.88%)
Pneumonitis † 1	1/14 (7.14%)	2/17 (11.76%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	1/41 (2.44%)
Pulmonary Embolism † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Pneumothorax † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Pleural Effusion † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Pulmonary Edema † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Skin and subcutaneous tissue disorders
Rash † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Surgical and medical procedures
Hospitalizations † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Vascular disorders
Deep Vein Thrombosis † 1	0/14 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Hypertension † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Hypotension † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Embolism † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
1 Term from vocabulary, MedDRA 17.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Cohort 1	Cohort 2	Cohort 2a	Cohort 3	Cohort 6	Cohorot 7	Cohort 8
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	14/14 (100.00%)	17/17 (100.00%)	16/16 (100.00%)	6/6 (100.00%)	17/17 (100.00%)	15/16 (93.75%)	41/41 (100.00%)
Blood and lymphatic system disorders
Lymphadenopathy † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	3/41 (7.32%)
Lymphopenia † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	0/41 (0.00%)
Anemia † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Iron Deficiency Anemia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Lymph Node Pain † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Neutropenia † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Cardiac disorders
Tachycardia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	3/41 (7.32%)
Palpitations † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	0/41 (0.00%)
Atrial Fibrillation † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Angina Pectoris † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Arrhythmia † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Atrioventricular Block First Degree † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Pericardial Effusion † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Ear and labyrinth disorders
Ear Pain † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	1/41 (2.44%)
Hearing Impaired † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Tinnitus † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Ear Pruritus † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Hypoacusis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Vertigo † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Endocrine disorders
Hypothyroidism † 1	1/14 (7.14%)	1/17 (5.88%)	1/16 (6.25%)	1/6 (16.67%)	2/17 (11.76%)	0/16 (0.00%)	6/41 (14.63%)
Hypophysitis † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	3/41 (7.32%)
Thyroiditis † 1	0/14 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Adrenal Insufficiency † 1	0/14 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Eye disorders
Vision Blurred † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	2/6 (33.33%)	1/17 (5.88%)	0/16 (0.00%)	4/41 (9.76%)
Dry Eye † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	1/6 (16.67%)	1/17 (5.88%)	2/16 (12.50%)	1/41 (2.44%)
Uveitis † 1	1/14 (7.14%)	2/17 (11.76%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Ocular Hyperemia † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	2/41 (4.88%)
Eye Pain † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	1/41 (2.44%)
Eye Pruritus † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Eye Swelling † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Eyelid Margin Crusting † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Hypermetropia † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Ophthalmoplegia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Photophobia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Vitreous Floaters † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Gastrointestinal disorders
Nausea † 1	7/14 (50.00%)	5/17 (29.41%)	4/16 (25.00%)	3/6 (50.00%)	4/17 (23.53%)	6/16 (37.50%)	20/41 (48.78%)
Diarrhea † 1	5/14 (35.71%)	6/17 (35.29%)	8/16 (50.00%)	4/6 (66.67%)	3/17 (17.65%)	4/16 (25.00%)	17/41 (41.46%)
Constipation † 1	4/14 (28.57%)	4/17 (23.53%)	4/16 (25.00%)	2/6 (33.33%)	2/17 (11.76%)	4/16 (25.00%)	10/41 (24.39%)
Abdominal Pain † 1	3/14 (21.43%)	3/17 (17.65%)	3/16 (18.75%)	1/6 (16.67%)	0/17 (0.00%)	1/16 (6.25%)	11/41 (26.83%)
Vomiting † 1	3/14 (21.43%)	3/17 (17.65%)	3/16 (18.75%)	1/6 (16.67%)	0/17 (0.00%)	1/16 (6.25%)	10/41 (24.39%)
Dry Mouth † 1	1/14 (7.14%)	0/17 (0.00%)	2/16 (12.50%)	1/6 (16.67%)	2/17 (11.76%)	2/16 (12.50%)	6/41 (14.63%)
Flatulence † 1	1/14 (7.14%)	2/17 (11.76%)	2/16 (12.50%)	1/6 (16.67%)	0/17 (0.00%)	1/16 (6.25%)	2/41 (4.88%)
Dyspepsia † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	6/41 (14.63%)
Abdominal Distension † 1	0/14 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	3/41 (7.32%)
Abdominal Pain Upper † 1	1/14 (7.14%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	2/41 (4.88%)
Dysphagia † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	2/16 (12.50%)	0/41 (0.00%)
Gastroesophageal Reflux Disease † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	1/41 (2.44%)
Hemorrhoids † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	1/41 (2.44%)
Colitis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Gingival Pain † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Glossodynia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	1/41 (2.44%)
Tongue Ulceration † 1	1/14 (7.14%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Anal Pruritis † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Anorectal Discomfort † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Aphthous Stomatitis † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Cheilitis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Gingival Bleeding † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Lip Dry † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Pancreatitis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Regurgitation † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Tongue Discoloration † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Tongue Edema † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
General disorders
Fatigue † 1	9/14 (64.29%)	11/17 (64.71%)	7/16 (43.75%)	4/6 (66.67%)	9/17 (52.94%)	7/16 (43.75%)	26/41 (63.41%)
Pyrexia † 1	5/14 (35.71%)	7/17 (41.18%)	3/16 (18.75%)	4/6 (66.67%)	2/17 (11.76%)	4/16 (25.00%)	14/41 (34.15%)
Chills † 1	3/14 (21.43%)	5/17 (29.41%)	1/16 (6.25%)	0/6 (0.00%)	1/17 (5.88%)	2/16 (12.50%)	7/41 (17.07%)
Edema Peripheral † 1	2/14 (14.29%)	2/17 (11.76%)	1/16 (6.25%)	1/6 (16.67%)	1/17 (5.88%)	3/16 (18.75%)	4/41 (9.76%)
Pain † 1	0/14 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	2/6 (33.33%)	0/17 (0.00%)	1/16 (6.25%)	2/41 (4.88%)
Asthenia † 1	0/14 (0.00%)	1/17 (5.88%)	2/16 (12.50%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	2/41 (4.88%)
Edema † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	2/41 (4.88%)
Chest Pain † 1	2/14 (14.29%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Chest Discomfort † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	1/41 (2.44%)
Influenza Like Illness † 1	0/14 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Mucosal Inflammation † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	1/41 (2.44%)
Xerosis † 1	3/14 (21.43%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Axillary Pain † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Local Swelling † 1	1/14 (7.14%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Thirst † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Catheter Site Pain † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Early Satiety † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Facial Pain † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Feeling Jittery † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Hernia † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Injection Site Reaction † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Sensation of Foreign Body † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Hepatobiliary disorders
Hyperbilirubinemia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Immune system disorders
Hypersensitivity † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	1/41 (2.44%)
Infections and infestations
Upper Respiratory Tract Infections † 1	1/14 (7.14%)	2/17 (11.76%)	1/16 (6.25%)	1/6 (16.67%)	2/17 (11.76%)	1/16 (6.25%)	3/41 (7.32%)
Urinary Tract Infections † 1	0/14 (0.00%)	3/17 (17.65%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	2/41 (4.88%)
Nasopharyngitis † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	1/6 (16.67%)	1/17 (5.88%)	1/16 (6.25%)	0/41 (0.00%)
Bronchitis † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	2/41 (4.88%)
Candida Infection † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	3/41 (7.32%)
Conjunctivitis † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	1/41 (2.44%)
Oral Herpes † 1	1/14 (7.14%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Sinusitis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	1/16 (6.25%)	1/41 (2.44%)
Herpes Zoster † 1	0/14 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Influenza † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Appendicitis † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Cellulitis Orbital † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Clostridium Difficile Colitis † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Escherichia Bacteremia † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Respiratory Syncytial Virus Infection † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Tonsillitis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Tooth Abscess † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Viral Infection † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Wound Infection † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Injury, poisoning and procedural complications
Sunburn † 1	1/14 (7.14%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Contusion † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	1/41 (2.44%)
Fall † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Infusion Related Reaction † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Alcohol Poisoning † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Laceration † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Procedural Pain † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Radiation Necrosis † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Radiation Skin Injury † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Wound † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Investigations
Lipase Increased † 1	2/14 (14.29%)	4/17 (23.53%)	3/16 (18.75%)	4/6 (66.67%)	2/17 (11.76%)	1/16 (6.25%)	8/41 (19.51%)
Amylase Increased † 1	2/14 (14.29%)	4/17 (23.53%)	2/16 (12.50%)	3/6 (50.00%)	1/17 (5.88%)	0/16 (0.00%)	6/41 (14.63%)
Aspartate Aminotransferase Increased † 1	2/14 (14.29%)	1/17 (5.88%)	1/16 (6.25%)	4/6 (66.67%)	1/17 (5.88%)	0/16 (0.00%)	7/41 (17.07%)
Weight Decreased † 1	2/14 (14.29%)	1/17 (5.88%)	3/16 (18.75%)	2/6 (33.33%)	1/17 (5.88%)	2/16 (12.50%)	5/41 (12.20%)
Alanine Aminotransferase Increased † 1	1/14 (7.14%)	4/17 (23.53%)	0/16 (0.00%)	2/6 (33.33%)	0/17 (0.00%)	1/16 (6.25%)	7/41 (17.07%)
Hemoglobin Decreased † 1	1/14 (7.14%)	1/17 (5.88%)	0/16 (0.00%)	1/6 (16.67%)	1/17 (5.88%)	1/16 (6.25%)	3/41 (7.32%)
Weight Increased † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	1/17 (5.88%)	1/16 (6.25%)	3/41 (7.32%)
Blood Lactate Dehydrogenase Increased † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	6/41 (14.63%)
Blood Alkaline Phosphatase Increased † 1	2/14 (14.29%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	3/41 (7.32%)
Blood Creatinine Increased † 1	2/14 (14.29%)	1/17 (5.88%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Gamma-Glutamyltransferase Increased † 1	2/14 (14.29%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Blood Thyroid Stimulating Hormone Decreased † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	2/41 (4.88%)
Electrocardiogram QT Prolonged † 1	0/14 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
International Normalized Ratio Increased † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	1/41 (2.44%)
Blood Albumin Decreased † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Blood Phosphorus Increased † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Blood Potassium Increased † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Blood Testosterone Decreased † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Blood Uric Acid Increased † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Breath Sounds Abnormal † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Chest X-Ray Abnormal † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Fungal Test Positive † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Thyroid Function Test Abnormal † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Transaminases Increased † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Metabolism and nutrition disorders
Decreased Appetite † 1	3/14 (21.43%)	4/17 (23.53%)	3/16 (18.75%)	0/6 (0.00%)	2/17 (11.76%)	1/16 (6.25%)	5/41 (12.20%)
Hyperglycemia † 1	2/14 (14.29%)	0/17 (0.00%)	1/16 (6.25%)	1/6 (16.67%)	2/17 (11.76%)	1/16 (6.25%)	2/41 (4.88%)
Hypokalemia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	8/41 (19.51%)
Hypoalbuminemia † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	3/41 (7.32%)
Dehydration † 1	2/14 (14.29%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	2/41 (4.88%)
Hyponatremia † 1	1/14 (7.14%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	1/41 (2.44%)
Hyperuricemia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	3/41 (7.32%)
Hyperphosphatemia † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	2/16 (12.50%)	1/41 (2.44%)
Hypocalcemia † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Hyperkalemia † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Hypoglycemia † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Increased Appetite † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Polydipsia † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Musculoskeletal and connective tissue disorders
Arthalgia † 1	5/14 (35.71%)	3/17 (17.65%)	3/16 (18.75%)	2/6 (33.33%)	4/17 (23.53%)	7/16 (43.75%)	12/41 (29.27%)
Back Pain † 1	3/14 (21.43%)	1/17 (5.88%)	4/16 (25.00%)	2/6 (33.33%)	2/17 (11.76%)	2/16 (12.50%)	2/41 (4.88%)
Myalgia † 1	2/14 (14.29%)	2/17 (11.76%)	0/16 (0.00%)	0/6 (0.00%)	3/17 (17.65%)	3/16 (18.75%)	4/41 (9.76%)
Pain in Extremity † 1	4/14 (28.57%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	3/41 (7.32%)
Muscle Spasms † 1	3/14 (21.43%)	0/17 (0.00%)	3/16 (18.75%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	4/41 (9.76%)
Musculoskeletal Chest Pain † 1	1/14 (7.14%)	1/17 (5.88%)	2/16 (12.50%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	3/41 (7.32%)
Neck Pain † 1	1/14 (7.14%)	2/17 (11.76%)	1/16 (6.25%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	2/41 (4.88%)
Musculoskeletal Pain † 1	1/14 (7.14%)	0/17 (0.00%)	1/16 (6.25%)	1/6 (16.67%)	1/17 (5.88%)	0/16 (0.00%)	1/41 (2.44%)
Joint Swelling † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	1/41 (2.44%)
Flank Pain † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	0/41 (0.00%)
Pain in Jaw † 1	1/14 (7.14%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Groin Pain † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Joint Stiffness † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Muscle Tightness † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Musculoskeletal Stiffness † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumor Pain † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Acrochordon † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Basal Cell Carcinoma † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Squamous Cell Carcinoma † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Tumor Hemorrhage † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Nervous system disorders
Headache † 1	2/14 (14.29%)	8/17 (47.06%)	4/16 (25.00%)	4/6 (66.67%)	1/17 (5.88%)	3/16 (18.75%)	13/41 (31.71%)
Dizziness † 1	2/14 (14.29%)	3/17 (17.65%)	1/16 (6.25%)	0/6 (0.00%)	2/17 (11.76%)	3/16 (18.75%)	4/41 (9.76%)
Neuropathy Peripheral † 1	4/14 (28.57%)	3/17 (17.65%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	1/41 (2.44%)
Dysgeusia † 1	1/14 (7.14%)	3/17 (17.65%)	2/16 (12.50%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	2/41 (4.88%)
Ataxia † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	1/41 (2.44%)
Hypoaesthesia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	2/41 (4.88%)
Tremor † 1	0/14 (0.00%)	1/17 (5.88%)	2/16 (12.50%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Ageusia † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Amnesia † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Lethargy † 1	1/14 (7.14%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Presyncope † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Carpal Tunnel Syndrome † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Cognitive Disorder † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Dizziness Postural † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Dysarthria † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Hemiparesis † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Memory Impairment † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Migraine with Aura † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Mononeuropathy † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Narcolepsy † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Sciatica † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Sinus Headache † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Somnolence † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Psychiatric disorders
Insomnia † 1	2/14 (14.29%)	1/17 (5.88%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	4/41 (9.76%)
Anxiety † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	2/41 (4.88%)
Depression † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	2/41 (4.88%)
Confusional State † 1	0/14 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Mood Altered † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	2/17 (11.76%)	0/16 (0.00%)	0/41 (0.00%)
Mental Status Changes † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Renal and urinary disorders
Pollakiuria † 1	2/14 (14.29%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	1/41 (2.44%)
Dysuria † 1	2/14 (14.29%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Hematuria † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	2/16 (12.50%)	1/41 (2.44%)
Micturition Urgency † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Chromaturia † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Polyuria † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Urethral Discharge † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Urinary Tract Disorder † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Reproductive system and breast disorders
Breast Cyst † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Gynecomastia † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Polymenorrhea † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Vaginal Hemorrhage † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Vulvovaginal Dryness † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	5/14 (35.71%)	6/17 (35.29%)	7/16 (43.75%)	2/6 (33.33%)	5/17 (29.41%)	6/16 (37.50%)	17/41 (41.46%)
Dyspnea † 1	3/14 (21.43%)	2/17 (11.76%)	3/16 (18.75%)	1/6 (16.67%)	1/17 (5.88%)	2/16 (12.50%)	7/41 (17.07%)
Nasal Congestion † 1	0/14 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	0/6 (0.00%)	2/17 (11.76%)	1/16 (6.25%)	6/41 (14.63%)
Dyspnea Exertional † 1	2/14 (14.29%)	1/17 (5.88%)	0/16 (0.00%)	1/6 (16.67%)	3/17 (17.65%)	0/16 (0.00%)	0/41 (0.00%)
Rhinorrhoea † 1	2/14 (14.29%)	1/17 (5.88%)	1/16 (6.25%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	2/41 (4.88%)
Sinus Congestion † 1	1/14 (7.14%)	1/17 (5.88%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	4/41 (9.76%)
Upper-Airway Cough Syndrome † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	2/17 (11.76%)	1/16 (6.25%)	2/41 (4.88%)
Oropharyngeal Pain † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	3/41 (7.32%)
Wheezing † 1	1/14 (7.14%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/41 (0.00%)
Dysphonia † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Epistaxis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	1/41 (2.44%)
Pneumonitis † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Productive Cough † 1	0/14 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Respiratory Tract Inflammation † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Throat Tightness † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Pulmonary Mass † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Sleep Apnea Syndrome † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Skin and subcutaneous tissue disorders
Rash † 1	9/14 (64.29%)	11/17 (64.71%)	11/16 (68.75%)	4/6 (66.67%)	7/17 (41.18%)	5/16 (31.25%)	27/41 (65.85%)
Pruritus † 1	8/14 (57.14%)	11/17 (64.71%)	12/16 (75.00%)	3/6 (50.00%)	4/17 (23.53%)	4/16 (25.00%)	22/41 (53.66%)
Vitiligo † 1	2/14 (14.29%)	4/17 (23.53%)	3/16 (18.75%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	4/41 (9.76%)
Alopecia † 1	0/14 (0.00%)	1/17 (5.88%)	2/16 (12.50%)	0/6 (0.00%)	0/17 (0.00%)	3/16 (18.75%)	5/41 (12.20%)
Dry Skin † 1	1/14 (7.14%)	1/17 (5.88%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	5/41 (12.20%)
Night Sweats † 1	2/14 (14.29%)	2/17 (11.76%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	2/41 (4.88%)
Erythema † 1	2/14 (14.29%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	1/41 (2.44%)
Rash Papular † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	5/41 (12.20%)
Rash Pruritic † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	3/41 (7.32%)
Rash Macular † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	3/41 (7.32%)
Urticaria † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	1/41 (2.44%)
Palmar-Plantar Erythrodysaesthesia Syndrome † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	2/16 (12.50%)	0/41 (0.00%)
Rash Maculo-Papular † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	1/41 (2.44%)
Skin Fissures † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Acne † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Acute Febrile Neutrophilic Dermatosis † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Blister † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Butterfly Rash † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/6 (16.67%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Dermatitis † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Hair Color Changes † 1	0/14 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Hyperhidrosis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
Lichenoid Keratosis † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Photodermatosis † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Photosensitivity Reaction † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Skin Irritation † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Vascular disorders
Hypertension † 1	1/14 (7.14%)	1/17 (5.88%)	3/16 (18.75%)	0/6 (0.00%)	0/17 (0.00%)	2/16 (12.50%)	2/41 (4.88%)
Hypotension † 1	3/14 (21.43%)	1/17 (5.88%)	1/16 (6.25%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Flushing † 1	1/14 (7.14%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	1/41 (2.44%)
Hemorrhage † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	1/17 (5.88%)	1/16 (6.25%)	0/41 (0.00%)
Deep Vein Thrombosis † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Hot Flush † 1	0/14 (0.00%)	1/17 (5.88%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/41 (0.00%)
Thrombophlebitis † 1	0/14 (0.00%)	0/17 (0.00%)	0/16 (0.00%)	0/6 (0.00%)	0/17 (0.00%)	1/16 (6.25%)	0/41 (0.00%)
1 Term from vocabulary, MedDRA 17.0; † Indicates events were collected by 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.

Results Point of Contact

• Name/Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb
• Phone: Please Email
• EMail: Clinical.Trials@bms.com

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

Callahan MK, Kluger H, Postow MA, Segal NH, Lesokhin A, Atkins MB, Kirkwood JM, Krishnan S, Bhore R, Horak C, Wolchok JD, Sznol M. Nivolumab Plus Ipilimumab in Patients With Advanced Melanoma: Updated Survival, Response, and Safety Data in a Phase I Dose-Escalation Study. J Clin Oncol. 2018 Feb 1;36(4):391-398. doi: 10.1200/JCO.2017.72.2850. Epub 2017 Oct 17.

Nguyen AT, Elia M, Materin MA, Sznol M, Chow J. Cyclosporine for Dry Eye Associated With Nivolumab: A Case Progressing to Corneal Perforation. Cornea. 2016 Mar;35(3):399-401. doi: 10.1097/ICO.0000000000000724.

Wolchok JD, Kluger H, Callahan MK, Postow MA, Rizvi NA, Lesokhin AM, Segal NH, Ariyan CE, Gordon RA, Reed K, Burke MM, Caldwell A, Kronenberg SA, Agunwamba BU, Zhang X, Lowy I, Inzunza HD, Feely W, Horak CE, Hong Q, Korman AJ, Wigginton JM, Gupta A, Sznol M. Nivolumab plus ipilimumab in advanced melanoma. N Engl J Med. 2013 Jul 11;369(2):122-33. doi: 10.1056/NEJMoa1302369. Epub 2013 Jun 2. Erratum In: N Engl J Med. 2018 Nov 29;379(22):2185.

• Responsible Party: Bristol-Myers Squibb
• ClinicalTrials.gov Identifier: NCT01024231
• Other Study ID Numbers: CA209-004; (MDX1106-04) ( Other Identifier: Medarex )
• First Submitted: December 1, 2009
• First Posted: December 2, 2009
• Results First Submitted: August 28, 2020
• Results First Posted: March 22, 2021
• Last Update Posted: March 22, 2021