Ofatumumab Bendamustine Combination Compared With Bendamustine Monotherapy in Indolent B-cell NHL Unresponsive to Rituxtherapy (A+B)

• ClinicalTrials.gov Identifier: NCT01077518
• Recruitment Status: Terminated
• First Posted: March 1, 2010
• Results First Posted: March 27, 2020
• Last Update Posted: March 27, 2020
• Sponsor: Novartis Pharmaceuticals
• Information provided by (Responsible Party): Novartis ( Novartis Pharmaceuticals )

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Lymphoma, Follicular
• Interventions: Drug: Ofatumumab; Drug: Bendamustine infusion; Drug: Ofatumumab and Bendamustine infusions (Arm A); Drug: Bendamustine infusion (Arm B)
• Enrollment: 346

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)	Optional Ofa
Arm/Group Description	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days	Participants from the Benda arm who opted for optional ofatumumab therapy post disease progression.
Period Title: Treatment Phase - no Optional Ofa
Started	173	173	0
Completed 5-year Follow-up	64	64	0
Safety Population	172	170	0
Completed	95	108	0
Not Completed	78	65	0
Reason Not Completed
Lost to Follow-up	8	4	0
Physician Decision	10	11	0
Study Terminated by Sponsor	28	22	0
Withdrawal by Subject	32	28	0
Period Title: Optional Ofa Phase
Started	0	0	32
Completed 5-year Follow-up	0	0	12
Completed	0	0	16
Not Completed	0	0	16
Reason Not Completed
Physician Decision	0	0	1
Study Terminated by Sponsor	0	0	12
Withdrawal by Subject	0	0	3

Baseline Characteristics

Arm/Group Title		Ofa + Benda (Arm A)	Benda (Arm B)	Total
Arm/Group Description		ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days	Total of all reporting groups
Overall Number of Baseline Participants		173	173	346
Baseline Analysis Population Description		Intent-to-Treat (ITT):
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	173 participants	173 participants	346 participants
		61.8 (61.0)	62.6 (63.0)	62.2 (62.0)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	173 participants	173 participants	346 participants
	Female	72 41.6%	71 41.0%	143 41.3%
	Male	101 58.4%	102 59.0%	203 58.7%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	173 participants	173 participants	346 participants
	Hispanic or Latino	10 5.8%	6 3.5%	16 4.6%
	Not Hispanic or Latino	163 94.2%	167 96.5%	330 95.4%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
FLIPI-1 Score at Screening [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	173 participants	173 participants	346 participants
0 - 2		100	93	193
3 - 5		66	75	141
Missing		7	5	12
		[1] Measure Description: Follicular Lymphoma International Prognostic Index-1 (FLIPI) is a prognostic tool that may be used to evaluate & select treatments based on differences in survival between risk groups. Low: (0 - 1) corresponds to better survival rate; intermediate: 2, corresponds to intermediate survival rate & high: (>=3) corresponds to worse survival rate. This index uses parameters related to subject characteristics such as age, tumor burden (Ann Arbor stage, number of nodal sites), tumor aggressiveness (serum Lactate Dehydrogenase (LDH) level), & consequences of the lymphoma on the host (hemoglobin level).
Baseline Absolute Lymphocyte Count (ALC) [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	173 participants	173 participants	346 participants
< (Lower limit of normal (LLN)		41	41	82
>= LLN		131	131	262
Missing		1	1	2
		[1] Measure Description: LLN - equal to the 5th percentile of a healthy, non-smoking population
Fc Gamma Receptor (FcR) Gamma 3A Variation; Measure Type: Number; Unit of measure: Participants	Number Analyzed	173 participants	173 participants	346 participants
GG		21	18	39
TG		77	59	136
TT		61	62	123
Missing		14	34	48
Human Anti-Chimeric Antibodies (HACA); Measure Type: Number; Unit of measure: Participants	Number Analyzed	173 participants	173 participants	346 participants
Negative		141	116	257
Positive		21	23	44
Missing		11	34	45

Outcome Measures

1. Primary Outcome

Title	Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
Description	PFS is defined as the time interval between randomization until disease progression or death (due to any cause).
Time Frame	From randomization to the date of first documented disease progression or death due to any cause (67.5 months)

Outcome Measure Data

Analysis Population Description

ITT: The Intent-to-Treat (ITT) population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	173	173
Median (95% Confidence Interval); Unit of Measure: months
	16.66; (12.81 to 19.68)	13.83; (11.30 to 16.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ofa + Benda (Arm A), Benda (Arm B)
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1390
	Comments	[Not Specified]
	Method	Stratified Log-Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Stratified Cox propor.hazards regression
	Estimated Value	0.82
	Confidence Interval	(2-Sided) 95%; 0.62 to 1.07
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Progression-free Survival (PFS) in Participants With Follicular Lymphoma (FL) Per IRC
Description	PFS is defined as the time interval between randomization until disease progression or death (due to any cause).
Time Frame	From randomization to the date of first documented disease progression or death due to any cause (67.5 months)

Outcome Measure Data

Analysis Population Description

Subjects in ITT with Follicular Lymphoma (FL). ITT population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	120	119
Median (95% Confidence Interval); Unit of Measure: months
	16.62; (11.17 to 20.47)	12.12; (10.94 to 16.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ofa + Benda (Arm A), Benda (Arm B)
	Comments	[Not Specified]
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1076
	Comments	[Not Specified]
	Method	Stratified Log-Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Stratified Cox propor.hazards regression
	Estimated Value	0.76
	Confidence Interval	(2-Sided) 95%; 0.55 to 1.06
	Estimation Comments	[Not Specified]

3. Secondary Outcome

Title	Overall Response Rate (ORR) in All Participants Per IRC
Description	ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions.
Time Frame	From randomization until the 217th PFS event occurred, up to about 67.5 months

Outcome Measure Data

Analysis Population Description

ITT: The ITT population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	173	173
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	73; (66 to 80)	75; (67 to 81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ofa + Benda (Arm A), Benda (Arm B)
	Comments	for All participants
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8003
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	adjusted for stratum

4. Secondary Outcome

Title	Overall Response Rate (ORR) in Participants With FL Per IRC
Description	ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions.
Time Frame	From randomization until the 217th PFS event occurred, up to about 67.5 months

Outcome Measure Data

Analysis Population Description

Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	120	119
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	77; (68 to 84)	76; (67 to 83)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ofa + Benda (Arm A), Benda (Arm B)
	Comments	for Follicular Lymphoma (FL) participants
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6130
	Comments	[Not Specified]
	Method	Cochran-Mantel-Haenszel
	Comments	adjusted for stratum

5. Secondary Outcome

Title	Overall Survival (OS) in All Participants
Description	The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact.
Time Frame	From randomization up to about 89 months

Outcome Measure Data

Analysis Population Description

ITT: The ITT population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	173	173
Median (95% Confidence Interval); Unit of Measure: months
	59.76 [1]; (46.63 to NA)	58.22 [1]; (36.44 to NA)

[1]

NA = Not evaluable because of a lot of censored data

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ofa + Benda (Arm A), Benda (Arm B)
	Comments	for All patients
	Type of Statistical Test	Other
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4046
	Comments	[Not Specified]
	Method	Stratified Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.87
	Confidence Interval	(2-Sided) 95%; 0.62 to 1.21
	Estimation Comments	[Not Specified]

6. Secondary Outcome

Title	Overall Survival (OS) in Participants With FL
Description	The interval of time between the date of randomization and the date of death due to any cause. For subjects who are alive, time of death will be censored at the date of last contact.
Time Frame	From randomization up to about 89 months

Outcome Measure Data

Analysis Population Description

Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	120	119
Median (95% Confidence Interval); Unit of Measure: months
	NA [1]; (45.60 to NA)	53.59 [1]; (36.44 to NA)

[1]

NA = Not evaluable because of a lot of censored data

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ofa + Benda (Arm A), Benda (Arm B)
	Comments	for FL participants
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3768
	Comments	[Not Specified]
	Method	Stratified Log Rank
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Hazard Ratio (HR)
	Estimated Value	0.83
	Confidence Interval	(2-Sided) 95%; 0.55 to 1.25
	Estimation Comments	[Not Specified]

7. Secondary Outcome

Title	Time to Response in All Participants Per IRC
Description	Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment.
Time Frame	From randomization to up to 67.5 months

Outcome Measure Data

Analysis Population Description

ITT: The ITT population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	173	173
Median (95% Confidence Interval); Unit of Measure: Months
	2.86; (2.83 to 2.92)	2.89; (2.83 to 2.92)

8. Secondary Outcome

Title	Time to Response in Participants With FL Per IRC
Description	Time to response = time from randomization to the first response (CR/ PR). If no CR/PR value was present data was to be censored at last adequate assessment.
Time Frame	From randomization to up to 67.5 months

Outcome Measure Data

Analysis Population Description

Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	120	119
Median (95% Confidence Interval); Unit of Measure: Months
	2.86; (2.83 to 2.92)	2.86; (2.83 to 2.89)

9. Secondary Outcome

Title	Duration of Response in All Participants Per IRC
Description	Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause.
Time Frame	time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months

Outcome Measure Data

Analysis Population Description

ITT: The ITT population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	173	173
Median (95% Confidence Interval); Unit of Measure: months
	17.71; (13.04 to 22.57)	14.49; (10.84 to 16.76)

10. Secondary Outcome

Title	Duration of Response in Participants With FL Per IRC
Description	Time (in months) from the initial response (CR/PR) to first documented sign of disease progression or death due to any cause.
Time Frame	time from the initial response (CR/PR) (Day 84) to first documented sign of disease progression or death due to any cause up to 67.5 months

Outcome Measure Data

Analysis Population Description

Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	120	119
Median (95% Confidence Interval); Unit of Measure: months
	16.39; (11.53 to 20.53)	11.20; (8.61 to 16.43)

11. Secondary Outcome

Title	Time to Progression in All Participants Per IRC
Description	Time from randomization until disease progression
Time Frame	From randomization to the date of first documented disease progression, whichever occurred first, reported betwen day of first participant randomized up to about 67.5 months

Outcome Measure Data

Analysis Population Description

ITT: The ITT population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	173	173
Median (95% Confidence Interval); Unit of Measure: Months
	19.35; (14.32 to 23.10)	16.56; (13.63 to 19.75)

12. Secondary Outcome

Title	Time to Progression in Participants With FL Per IRC
Description	Time from randomization until disease progression
Time Frame	From randomization to the date of first documented disease progression, whichever occurred first, reported betwen day of first participant randomized up to about 67.5 months

Outcome Measure Data

Analysis Population Description

Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	120	119
Median (95% Confidence Interval); Unit of Measure: Months
	19.35; (14.16 to 24.87)	13.80; (11.14 to 16.85)

13. Secondary Outcome

Title	Time to Next Therapy in All Participants Per IRC
Description	Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types.
Time Frame	from randomization date to the date of receiving the next line treatment or death, up to 67.5 months

Outcome Measure Data

Analysis Population Description

ITT: The ITT population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	173	173
Median (95% Confidence Interval); Unit of Measure: Months
	39.82 [1]; (28.81 to NA)	26.94; (21.72 to 39.75)

[1]

NA = Not evaluable because of a lot of censored data

14. Secondary Outcome

Title	Time to Next Therapy in Participants With FL Per IRC
Description	Time to next therapy was defined as the time (in months) from randomization date to the date of receiving the next line treatment, including all therapy types
Time Frame	from randomization date to the date of receiving the next line treatment or death, up to 67.5 months

Outcome Measure Data

Analysis Population Description

Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	120	119
Median (95% Confidence Interval); Unit of Measure: Months
	36.96 [1]; (23.79 to NA)	25.43; (18.37 to 47.70)

[1]

NA = Not evaluable because of a lot of censored data

15. Secondary Outcome

Title	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in All Participants: The FACT-Lym
Description	The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is intended as a lymphoma specific additional concerns subscale that is designed to supplement the FACT-G. The subscale consists of 15 items. Subjects respond to the items on a five point Likert scale ranging from 0 'Not at all' to 4 'Very much'. Subscale scores are calculated by summing individual items to obtain a score, then multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered. The Score range is 0 -28 for Physical Well-Being, Social/Family Well-Being, 0 -24 for Functional Well-Being and 0 - 60 for the Lymphoma subscale (LYMS). FACT lymphoma TOI is the sum of Physical, Functional Well-Being & Lymphoma scores. FACT-G Total Score is the sum of Physical, Emotional, Social and Functional Well-Being scores. FACT-Lymph is the sum of Physical, Social, Emotional, Functional and Lymphoma scores. The higher the score, the better the QOL. C =cycle; D=Day
Time Frame	administered at the screening visit and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Outcome Measure Data

Analysis Population Description

ITT: The ITT population included subjects who were randomized in the study.

Arm/Group Title		Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:		ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed		173	173
Mean (Standard Deviation); Unit of Measure: scores on a scale
Physical well-being score: C5D1	Number Analyzed	126 participants	118 participants
		0.2 (4.36)	-2.8 (5.54)
Physical well-being score C11D1	Number Analyzed	104 participants	78 participants
		1.1 (4.58)	1.0 (4.25)
Physical well-being score D252	Number Analyzed	3 participants	6 participants
		-5.0 (9.64)	1.7 (9.18)
Physical well-being score 12M post-D252	Number Analyzed	67 participants	53 participants
		0.9 (5.59)	1.3 (4.52)
Physical well-being score Withdrawal	Number Analyzed	12 participants	15 participants
		-4.1 (6.78)	-1.5 (6.61)
Social/Family well-being score C5D1	Number Analyzed	126 participants	118 participants
		0.2 (4.94)	-0.5 (5.24)
Social/Family well-being score C11D1	Number Analyzed	104 participants	78 participants
		-1.2 (6.09)	-1.1 (6.45)
Social/Family well-being score D252	Number Analyzed	3 participants	6 participants
		-1.6 (3.24)	-5.4 (9.08)
Soc./Fam. well-being score 12M post-D252	Number Analyzed	67 participants	53 participants
		0.3 (5.21)	-1.3 (4.81)
Social/Family well-being score Withdrawal	Number Analyzed	12 participants	15 participants
		0.9 (7.69)	0.3 (3.53)
Emotional well-being score C5D1	Number Analyzed	126 participants	118 participants
		1.7 (3.97)	0.1 (4.10)
Emotional well-being score C11D1	Number Analyzed	103 participants	78 participants
		1.4 (4.12)	0.7 (3.90)
Emotional well-being score D252	Number Analyzed	3 participants	6 participants
		-5.3 (2.08)	-2.5 (5.89)
Emotional well-being score 12M post-D252	Number Analyzed	67 participants	53 participants
		1.5 (4.45)	0.7 (4.15)
Emotional well-being score Withdrawal	Number Analyzed	12 participants	15 participants
		-2.2 (4.80)	-2.3 (4.12)
Functional well-being score C5D1	Number Analyzed	126 participants	118 participants
		0.7 (5.08)	-1.5 (5.79)
Functional well-being score C11D1	Number Analyzed	103 participants	78 participants
		1.1 (5.62)	-0.6 (5.52)
Functional well-being score D252	Number Analyzed	3 participants	6 participants
		-4.3 (5.69)	-2.2 (13.76)
Functional well-being score 12M post-D252	Number Analyzed	67 participants	53 participants
		1.1 (4.82)	0.8 (5.55)
Functional well-being score Withdrawal	Number Analyzed	12 participants	15 participants
		-2.3 (4.27)	-1.6 (6.47)
Lymphoma subscale score C5D1	Number Analyzed	126 participants	118 participants
		3.6 (7.88)	-1.0 (9.65)
Lymphoma subscale score C11D1	Number Analyzed	104 participants	78 participants
		4.4 (8.88)	2.3 (6.53)
Lymphoma subscale score D252	Number Analyzed	3 participants	6 participants
		-2.3 (14.98)	0.7 (18.22)
Lymphoma subscale score 12M post-D252	Number Analyzed	67 participants	53 participants
		3.2 (7.77)	2.0 (7.71)
Lymphoma subscale score Withdrawal	Number Analyzed	12 participants	15 participants
		-1.4 (6.16)	-1.6 (7.65)
FACT-Lymphoma TOI C1D1	Number Analyzed	126 participants	118 participants
		4.5 (14.64)	-5.3 (18.67)
FACT-Lymphoma TOI C11D1	Number Analyzed	103 participants	78 participants
		6.7 (15.84)	2.7 (13.24)
FACT-Lymphoma TOI D252	Number Analyzed	3 participants	6 participants
		-11.7 (28.75)	0.2 (36.56)
FACT-Lymphoma TOI 12M post-D252	Number Analyzed	67 participants	53 participants
		5.1 (15.94)	4.1 (14.62)
FACT-Lymphoma TOI Withdrawal	Number Analyzed	12 participants	14 participants
		-7.8 (14.55)	-4.3 (16.77)
FACT-G Total Score C5D1	Number Analyzed	126 participants	118 participants
		2.7 (12.82)	-4.7 (15.26)
FACT-G Total Score C11D1	Number Analyzed	103 participants	78 participants
		2.3 (13.00)	0.1 (14.11)
FACT-G Total score D252	Number Analyzed	3 participants	6 participants
		-16.2 (15.71)	-8.4 (31.22)
FACT-G Total Score 12M post-D252	Number Analyzed	67 participants	53 participants
		3.7 (13.75)	1.5 (13.44)
FACT-G Total Score Withdrawal	Number Analyzed	12 participants	15 participants
		-7.7 (11.91)	-5.3 (13.10)
FACT-Lymph. Tot. score C5D1	Number Analyzed	126 participants	118 participants
		6.3 (18.78)	-5.8 (23.05)
FACT-Lymph. Tot. score C11D1	Number Analyzed	103 participants	78 participants
		6.7 (18.95)	2.4 (18.73)
FACT-Lymph. Tot. score D252	Number Analyzed	3 participants	6 participants
		-18.6 (30.50)	-7.7 (44.64)
FACT-Lymph. Tot. score 12M post-D252	Number Analyzed	67 participants	53 participants
		6.9 (19.78)	3.5 (18.77)
FACT-Lymph. Tot. score Withdrawal	Number Analyzed	12 participants	14 participants
		-9.1 (15.96)	-6.5 (18.53)

16. Secondary Outcome

Title	PRO - Change From Baseline in Health Related Quality of Life (HRQL) Measures in Participants With FL: The FACT-Lym
Description	The Functional Assessment of Cancer Therapy - Lymphoma (FACT-Lym) is intended as a lymphoma specific additional concerns subscale that is designed to supplement the FACT-G. The subscale consists of 15 items. Subjects respond to the items on a five point Likert scale ranging from 0 'Not at all' to 4 'Very much'. Subscale scores are calculated by summing individual items to obtain a score, then multiplying the sum of the item scores by the number of items in the subscale, then dividing by the number of items answered. The Score range is 0 -28 for Physical Well-Being, Social/Family Well-Being, 0 -24 for Functional Well-Being and 0 - 60 for the Lymphoma subscale (LYMS). FACT lymphoma TOI is the sum of Physical, Functional Well-Being & Lymphoma scores. FACT-G Total Score is the sum of Physical, Emotional, Social and Functional Well-Being scores. FACT-Lymph is the sum of Physical, Social, Emotional, Functional and Lymphoma scores. The higher the score, the better the QOL. C =cycle; D=Day
Time Frame	administered at the screeing visit and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Outcome Measure Data

Analysis Population Description

Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm/Group Title		Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:		ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed		120	119
Mean (Standard Deviation); Unit of Measure: scores on a scale
Physical well-being score C5D1	Number Analyzed	87 participants	78 participants
		0.0 (4.66)	-3.4 (5.87)
Physical well-being score C11D1	Number Analyzed	72 participants	47 participants
		0.9 (4.16)	1.2 (4.74)
Physical well-being score D252	Number Analyzed	1 participants	2 participants
		2.0 [1] (NA)	7.5 (17.68)
Physical well-being score 12M post-D252	Number Analyzed	48 participants	30 participants
		0.5 (6.15)	1.8 (4.37)
Physical well-being score Withdrawal	Number Analyzed	6 participants	11 participants
		-5.0 (7.64)	-0.6 (6.31)
Social/Family well-being score C5D1	Number Analyzed	87 participants	78 participants
		-0.1 (4.38)	-0.7 (5.48)
Social/Family well-being score C11D1	Number Analyzed	72 participants	47 participants
		-1.6 (5.38)	-1.4 (5.61)
Social/Family well-being score D252	Number Analyzed	1 participants	2 participants
		2.0 [1] (NA)	2.5 (3.54)
Soc./Fam. well-being score 12M post-D252	Number Analyzed	48 participants	30 participants
		0.3 (5.35)	-1.9 (5.14)
Social/Family well-being score Withdrawal	Number Analyzed	6 participants	11 participants
		1.1 (5.79)	0.6 (2.57)
Emotional well-being score C5D1	Number Analyzed	87 participants	78 participants
		1.8 (3.65)	-0.0 (4.41)
Emotional well-being score C11D1	Number Analyzed	72 participants	47 participants
		1.2 (4.30)	0.5 (4.10)
Emotional well-being score D252	Number Analyzed	1 participants	2 participants
		-6.0 [1] (NA)	-1.0 (9.90)
Emotional well-being score 12M post-D252	Number Analyzed	48 participants	30 participants
		1.5 (4.85)	0.6 (2.68)
Emotional well-being score Withdrawal	Number Analyzed	6 participants	11 participants
		-2.3 (5.28)	-1.9 (4.59)
Functional well-being score C5D1	Number Analyzed	87 participants	78 participants
		0.1 (4.58)	-1.7 (5.74)
Functional well-being score C11D1	Number Analyzed	72 participants	47 participants
		0.5 (4.99)	-0.0 (4.84)
Functional well-being score D252	Number Analyzed	1 participants	2 participants
		-6.0 [1] (NA)	7.0 (15.56)
Functional well-being score 12M post-D252	Number Analyzed	48 participants	30 participants
		0.7 (4.99)	1.0 (5.75)
Functional well-being score Withdrawal	Number Analyzed	6 participants	11 participants
		-1.6 (4.06)	-1.5 (7.15)
Lymphoma subscale score C5D1	Number Analyzed	87 participants	78 participants
		3.7 (7.33)	-2.2 (9.71)
Lymphoma subscale score C11D1	Number Analyzed	72 participants	47 participants
		3.7 (8.70)	2.4 (6.79)
Lymphoma subscale score D252	Number Analyzed	1 participants	2 participants
		-18.7 [1] (NA)	7.0 (38.18)
Lymphoma subscale score 12M post-D252	Number Analyzed	48 participants	30 participants
		2.6 (8.00)	2.2 (6.63)
Lymphoma subscale score Withdrawal	Number Analyzed	6 participants	11 participants
		-2.5 (6.76)	-0.4 (7.17)
FACT-Lymphoma TOI C5D1	Number Analyzed	87 participants	78 participants
		3.7 (13.51)	-7.3 (18.77)
FACT-Lymphoma TOI C11D1	Number Analyzed	72 participants	47 participants
		5.0 (14.74)	3.6 (14.01)
FACT-Lymphoma TOI D252	Number Analyzed	1 participants	2 participants
		-2.0 [1] (NA)	21.5 (71.42)
FACT-Lymphoma TOI 12M post-D252	Number Analyzed	48 participants	30 participants
		3.7 (16.94)	4.9 (12.32)
FACT-Lymphoma TOI Withdrawal	Number Analyzed	6 participants	10 participants
		-9.2 (15.40)	-1.7 (15.26)
FACT-G Total score C5D1	Number Analyzed	87 participants	78 participants
		1.7 (11.40)	-5.8 (16.32)
FACT-G Total score C11D1	Number Analyzed	72 participants	47 participants
		1.0 (12.17)	0.2 (13.96)
FACT-G Total score D252	Number Analyzed	1 participants	2 participants
		-8.0 [1] (NA)	16.0 (39.60)
FACT-G Total score 12M post-D252	Number Analyzed	48 participants	30 participants
		2.9 (14.62)	1.4 (11.25)
FACT-Lymphoma Tot. score C5D1	Number Analyzed	87 participants	78 participants
		5.4 (16.55)	-8.0 (24.11)
FACT-Lymphoma Tot. score C11D1	Number Analyzed	72 participants	47 participants
		4.7 (17.52)	2.7 (19.60)
FACT-Lymphoma Tot. score D252	Number Analyzed	1 participants	2 participants
		-6.0 [1] (NA)	23.0 (77.78)
FACT-Lymphoma Tot. score 12M post-D252	Number Analyzed	48 participants	30 participants
		5.5 (20.73)	3.6 (14.44)
FACT-Lymphoma Tot. score Withdrawal	Number Analyzed	6 participants	10 participants
		-10.4 (15.02)	-3.1 (18.48)

[1]

NA = Standard Deviation not available since only 1 participant was analyzed for the assessment

17. Secondary Outcome

Title	PRO - Change From Baseline in HRQL Measures in All Participants: The EQ-5D
Description	The EuroQoL Five-Dimension (EQ-5D) is a self-administered, generic, indirect utility measure used for health economic analysis.EQ-5D should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) *EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)
Time Frame	administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Outcome Measure Data

Analysis Population Description

ITT: The ITT population included subjects who were randomized in the study.

Arm/Group Title		Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:		ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed		173	173
Mean (Standard Deviation); Unit of Measure: scores on a scale
EQ5D01-EQ VAS Score C5D1	Number Analyzed	124 participants	115 participants
		5.8 (18.10)	-3.8 (19.25)
EQ5D01-EQ VAS Score C11D1	Number Analyzed	101 participants	78 participants
		12.9 (19.38)	2.7 (18.96)
EQ5D01-EQ VAS Score D252	Number Analyzed	3 participants	6 participants
		-11.7 (16.07)	-0.8 (19.66)
EQ5D01-EQ VAS Score 12M post-D252	Number Analyzed	65 participants	52 participants
		14.7 (19.71)	7.1 (19.14)
EQ5D01-EQ VAS Score Withdrawal	Number Analyzed	12 participants	15 participants
		-14.7 (17.03)	0.7 (34.41)
EuroQoL Tariffs C5D1	Number Analyzed	122 participants	116 participants
		0.21 (0.24)	0.0 (0.22)
EuroQoL Tariffs C11D1	Number Analyzed	102 participants	78 participants
		0.1 (0.22)	0.0 (0.19)
EuroQoL Tariffs D252	Number Analyzed	3 participants	6 participants
		-0.4 (0.79)	0.1 (0.36)
EuroQoL Tariffs 12M post-D252	Number Analyzed	65 participants	51 participants
		0.0 (0.22)	0.0 (0.20)
EuroQoL Tariffs Withdrawal	Number Analyzed	12 participants	15 participants
		-0.2 (0.22)	0.1 (0.32)

18. Secondary Outcome

Title	PRO - Change From Baseline in HRQL Measures in Participants With FL: The EQ-5D
Description	The EuroQoL Five-Dimension (EQ-5D) is a self-administered, generic, indirect utility measure used for health economic analysis.EQ-5D should be answered as one of 3 levels about current condition for 5 dimensions and was calculated total average by giving a weighting on 3 level of answers (EQ-5D levels into 'no problems' (level 1) and 'problems' (level 2 and 3)). Table of scores by each level for EQ-5D items: mobility(level 1=0, level2=0.069,level 3=0.314), self care(level 1=0, level2=0.104,level 3=0.214), usual activities(level 1=0, level2=0.036,level 3=0.094), pain/discomfort (level 1=0, level2=0.,level 3=0.386) and anxiety/depression(level 1=0, level2=0.071,level 3=0.2) *EQ-5D Total = 1 - 0.081 - (the score of the each level) - 0.269 (if at least one of level 3 presents)
Time Frame	administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Outcome Measure Data

Analysis Population Description

Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm/Group Title		Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:		ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed		120	119
Mean (Standard Deviation); Unit of Measure: scores on a scale
EQ5D01-EQ VAS Score C5D1	Number Analyzed	85 participants	76 participants
		5.5 (19.25)	-6.5 (18.83)
EQ5D01-EQ VAS Score C11D1	Number Analyzed	69 participants	47 participants
		12.9 (19.88)	1.1 (20.87)
EQ5D01-EQ VAS Score D252	Number Analyzed	1 participants	2 participants
		0.00 [1] (NA)	-7.5 (31.82)
EQ5D01-EQ VAS Score 12M post-D252	Number Analyzed	46 participants	29 participants
		14.2 (21.47)	6.7 (20.77)
EQ5D01-EQ VAS Score Withdrawal	Number Analyzed	6 participants	11 participants
		-18.5 (13.35)	5.4 (37.78)
EuroQoL Tariffs C5D1	Number Analyzed	84 participants	76 participants
		0.0 (0.24)	0.0 (0.23)
EuroQoL Tariffs C11D1	Number Analyzed	70 participants	47 participants
		0.1 (0.22)	0.0 (0.20)
EuroQoL Tariffs D252	Number Analyzed	1 participants	2 participants
		0.0 [1] (NA)	0.4 (0.53)
EuroQoL Tariffs 12M post-D252	Number Analyzed	46 participants	28 participants
		0.0 (0.22)	0.0 (0.16)
EuroQoL Tariffs Withdrawal	Number Analyzed	6 participants	11 participants
		-0.1 (0.16)	0.1 (0.36)

[1]

NA = Standard Deviation not available since only 1 participant was analyzed for the assessment

19. Secondary Outcome

Title	PRO - Change in Health Treatment in HRQL Measures in All Participants: The Health Change Questionnaire (HCQ)
Description	The Health Change Questionnaire,(HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions
Time Frame	administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Outcome Measure Data

Analysis Population Description

ITT: The ITT population included subjects who were randomized in the study.

Arm/Group Title		Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:		ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed		173	173
Mean (Standard Deviation); Unit of Measure: scores on a scale
Change in health treatment C5D1	Number Analyzed	124 participants	118 participants
		2.8 (1.81)	3.8 (2.29)
Change in health treatment C11D1	Number Analyzed	105 participants	77 participants
		2.6 (1.73)	2.5 (1.74)
Change in health treatment D252	Number Analyzed	3 participants	6 participants
		5.3 (2.52)	4.8 (2.56)
Change in health treatment 12M post D252	Number Analyzed	66 participants	50 participants
		2.4 (1.95)	2.6 (1.99)
Change in health treatment Withdrawal	Number Analyzed	11 participants	15 participants
		5.4 (3.32)	4.3 (2.63)

20. Secondary Outcome

Title	PRO - Change in Health Treatment in HRQL Measures in Participants With FL: The Health Change Questionnaire (HCQ)
Description	The Health Change Questionnaire, (HCQ) used is a nine item scale that asks the patient to rate change in status since beginning treatment on this study. For HCQ, values from 1 to 9 were assigned to the 9 responses in the HCQ questionnaire, ranging from 1 for 'my health is a great deal better' to 9 for 'my health is a great deal worse' since the beginning of the study. Lower scores represent better conditions
Time Frame	administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Outcome Measure Data

Analysis Population Description

Subjects in ITT with FL. ITT population included subjects who were randomized in the study.

Arm/Group Title		Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:		ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed		120	119
Mean (Standard Deviation); Unit of Measure: scores on a scale
Change in health treatment C5D1	Number Analyzed	86 participants	78 participants
		2.9 (1.93)	3.9 (2.25)
Change in health treatment C11D1	Number Analyzed	73 participants	46 participants
		2.7 (1.73)	2.4 (1.56)
Change in health treatment D252	Number Analyzed	1 participants	2 participants
		3.0 [1] (NA)	4.5 (3.54)
Change in health treatment 12M post D252	Number Analyzed	47 participants	27 participants
		2.7 (2.11)	2.1 (1.54)
Change in health treatment Withdrawal	Number Analyzed	5 participants	11 participants
		7.2 (1.79)	4.2 (2.96)

[1]

NA: Not enough participants to calculate SD

21. Secondary Outcome

Title	Reduction in Tumor Size
Description	Tumor size was measured by the mean change in the sum of the products of the greatest diameter (SPD) of the largest abnormal nodes from baseline to post-baseline by CT Scan.
Time Frame	baseline, post-baseline (up to 55 months)

Outcome Measure Data

Analysis Population Description

ITT: The ITT population included subjects who were randomized in the study.

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	173	173
Mean (Standard Deviation); Unit of Measure: mm^2
	-33.2 (44.08)	-32.8 (36.83)

22. Secondary Outcome

Title	Summary of Change in Eastern Cooperative Oncology Group (ECOG) Performance Status
Description	This is the number of participants with change in ECOG status. Change is measured categorically by "Improvement, deterioration and No change". Improvement is defined as decrease from baseline by at least one step on the ECOG performance status scale. Deteriorations is defined as increase from baseline by at least one step on the ECOG performance status scale. ECOG status to evaluate daily living: 0: Fully active, able to carry on all pre-disease performance without restriction; 1: Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2: Ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours; 3: Capable of only limited self-care, confined to bed or chair more than 50% of waking hours; 4: Completely disabled; cannot carry on any self care.Totally confined to bed or chai; 5: Dead
Time Frame	administered at screening and C5D1 (month 5), C11D1 (month 11), D252, 12m post-D252, withdrawal (24m post-D252) up to 67.5 months; Cycle = 21 days

Outcome Measure Data

Analysis Population Description

ITT: The ITT population included subjects who were randomized in the study.

Arm/Group Title		Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:		ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed		173	173
Measure Type: Number; Unit of Measure: participants
C5D1: Deteriorated	Number Analyzed	142 participants	134 participants
		18	24
C5D1: Improved	Number Analyzed	142 participants	134 participants
		30	22
C5D1: No Change	Number Analyzed	142 participants	134 participants
		94	88
C11D1: Deteriorated	Number Analyzed	115 participants	90 participants
		13	9
C11D1: Improved	Number Analyzed	115 participants	90 participants
		27	23
C11D1: No Change	Number Analyzed	115 participants	90 participants
		75	58
12M post D252: Deteriorated	Number Analyzed	70 participants	56 participants
		9	6
12M post-D252: Improved	Number Analyzed	70 participants	56 participants
		17	12
12M post-D252: No Change	Number Analyzed	70 participants	56 participants
		44	38
Withdrawal: Deteriorated	Number Analyzed	17 participants	21 participants
		7	8
Withdrawal: Improved	Number Analyzed	17 participants	21 participants
		2	2
Withdrawal: No Change	Number Analyzed	17 participants	21 participants
		8	11

23. Secondary Outcome

Title	Summary of Number of Participants With Human Anti-Human Antibodies (HAHA)
Description	A summary by responders and non-responders
Time Frame	From randomization up to about 67.5 months

Outcome Measure Data

Analysis Population Description

Safety: The Safety population included all subjects who received at least one dose of a study drug. Per protocol, HAHA was only collected for subjects in the Ofa+benda arm.

Arm/Group Title	Ofa + Benda (Arm A)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days
Overall Number of Participants Analyzed	151
Measure Type: Number; Unit of Measure: Participants
# of participants with post-Ofa HAHA results	151
with at least 1 conf. +ve post-Ofa HAHA result	1
-ve post-Ofa HAHA results, no Ofa conc. <200 ug/mL	6
-ve post-Ofa HAHA, at least 1 Ofa conc<200ug/mL	144

24. Secondary Outcome

Title	Overall Response Rate (ORR) to Optional Ofatumumab Monotherapy in Subjects Who Progressed During or Following Single-agent Bendamustine
Description	ORR: Percentage of subjects achieving complete response (CR) or partial response (PR) from the start of randomization until disease progression or the start of new anti-cancer therapy, including the optional ofatumumab for subjects in Arm B based on responses from the IRC assessment of best overall response using the Revised Response Criteria for Malignant Lymphoma (RRCML). Response criteria is CR, PR, standard disease (SD), progressive disease (PD) or not estimable. CR is the complete disappearance of all detectable clinical evidence of disease & disease-related symptoms. PR is at least a 50% decrease from baseline in the sum of the product of the diameters (SPD) of target lesions. SD is failure to attain the criteria needed for a CR, PR or PD. PD is the appearance of any new lesion more than 1.5 cm in any axis or at least a 50% increase from nadir in the SPD of target or non target lesions or at least a 50% increase in the longest diameter(SLD) or any Target or non target lesions.
Time Frame	From randomization until the 217th PFS event occurred, up to about 67.8 months

Outcome Measure Data

Analysis Population Description

ITT: The ITT population included subjects who were randomized in the study.

Arm/Group Title	Optional Ofa
Arm/Group Description:	Eligible benda arm participants who were offered optional ofatumumab following disease progression
Overall Number of Participants Analyzed	30
Measure Type: Number; Unit of Measure: Percentage of participants
	17

25. Secondary Outcome

Title	Quantitative Assessments of Immunoglobulins A, G and M (IgA, IgG, IgM)
Description	at scheduled visits for actual values as well as for change from baseline
Time Frame	Screening, C1D1, 1M post D252, 6M post D252, 12M post D252 up to 67.5 months; Cycle = 21 days

Outcome Measure Data

Analysis Population Description

Safety: The Safety population included all subjects who received at least one dose of a study drug (Ofa+benda arm only).

Arm/Group Title		Ofa + Benda (Arm A)
Arm/Group Description:		ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days
Overall Number of Participants Analyzed		172
Mean (Standard Deviation); Unit of Measure: g/L
IgA @ screening (BL)	Number Analyzed	1 participants
		0.7 [1] (NA)
IgG @ screening	Number Analyzed	1 participants
		4.7 [1] (NA)
IgM @ screening	Number Analyzed	1 participants
		0.6 [1] (NA)
IgA @ C1D1	Number Analyzed	134 participants
		1.3 (0.78)
IgG @ C1D1	Number Analyzed	153 participants
		7.7 (3.96)
IgM @ C1D1	Number Analyzed	120 participants
		1.4 (4.15)
IgA @ 1M post-D252	Number Analyzed	77 participants
		1.1 (0.74)
IgG @ 1M post-D252	Number Analyzed	90 participants
		7.1 (2.90)
IgM @ 1M post-D252	Number Analyzed	50 participants
		0.6 (0.68)
IgA @ 6M post D252	Number Analyzed	65 participants
		1.1 (0.59)
IgG @ 6M post D252	Number Analyzed	75 participants
		7.3 (2.97)
IgM @ 6M post D252	Number Analyzed	41 participants
		0.7 (0.97)
IgA @ 12M post D252	Number Analyzed	53 participants
		1.1 (1.2)
IgG @12M post D252	Number Analyzed	63 participants
		7.1 (3.31)
IgM @ 12M post D252	Number Analyzed	41 participants
		0.7 (0.66)

[1]

NA = SD not reached as too few participants

26. Secondary Outcome

Title	Plasma Ofatumumab Concentrations
Description	Concentrations of ofatumumab in plasma listed by actual relative time and summarized by nominal time.
Time Frame	C1D1, C7D1, C12D1, C1D1, C12D1, 12M post-D252, withdrawal up to 12 months follow up

Outcome Measure Data

Analysis Population Description

Pharmacokinetic Population: The Pharmacokinetic Population included all subjects who provided at least one evaluable PK concentration

Arm/Group Title		Ofa + Benda (Arm A)
Arm/Group Description:		ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days
Overall Number of Participants Analyzed		171
Mean (Standard Deviation); Unit of Measure: ug/mL
C1D1 pre-dose	Number Analyzed	166 participants
		1.1 (13.97)
C1D1 End of infusion (EOI)	Number Analyzed	64 participants
		262.0 (83.97)
C1D1 1h post-EOI	Number Analyzed	61 participants
		283.2 (227.11)
C7D1 pre-dose	Number Analyzed	128 participants
		153.6 (74.45)
C7D1 EOI	Number Analyzed	42 participants
		402.2 (148.78)
C7D1 1h post-EOI	Number Analyzed	39 participants
		419.1 (167.44)
C12D1 pre-dose	Number Analyzed	101 participants
		143.5 (75.58)
C12D1 EOI	Number Analyzed	27 participants
		392.0 (130.64)
12M post-D252	Number Analyzed	43 participants
		0.9 (2.53)
Withdrawal	Number Analyzed	13 participants
		29.6 (42.58)

27. Secondary Outcome

Title	B-cell Monitoring (CD19+, CD20+)
Description	The percent change of CD5+CD19+ and CD5-CD19+ from baseline was summarized to assess the treatment effect, to monitor the normal B-cell population, and to follow their recovery.
Time Frame	C5D1 (month 5), 1M post-D252, 9M post-D252, up to 67.5 months; Cycle = 21 days

Outcome Measure Data

Analysis Population Description

ITT: The ITT population included subjects who were randomized in the study.

Arm/Group Title		Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:		ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed		173	173
Mean (Standard Deviation); Unit of Measure: percentage change from baseline
C5D1: CD45+CD19+	Number Analyzed	18 participants	1 participants
		-94.0 (16.6)	-97.0 [1] (NA)
1M post-D252: CD45+CD19+	Number Analyzed	27 participants	0 participants
		-82.0 (77.0)
9M post-D252: CD45+CD19+	Number Analyzed	15 participants	0 participants
		1421.0 (5721.6)
C1D1: CD45+CD20+	Number Analyzed	17 participants	1 participants
		-100.0 (0.0)	-98.0 [1] (NA)
1M post-D252: CD45+CD20+	Number Analyzed	26 participants	0 participants
		-100.0 (0.0)
9M post-D252: CD45+CD20+	Number Analyzed	15 participants	0 participants
		925.0 (3803.1)

[1]

NA: Not enough participants to calculate SD

28. Secondary Outcome

Title	Human Anti-chimeric Antibodies (HACA) Over Time
Description	The number of participants with positive and negative baseline HACA results
Time Frame	At Baseline and Cycle 1 day 1

Outcome Measure Data

Analysis Population Description

Safety: The Safety population included all subjects who received at least one dose of a study drug

Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)
Arm/Group Description:	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days
Overall Number of Participants Analyzed	170	142
Measure Type: Number; Unit of Measure: Participants
Baseline: Negative	145	119
Baseline: Positive	25	23
C1D1: Negative	145	119
C1D1:Positive	25	23

Adverse Events

Time Frame	Adverse Event (AE) timeframe: Adverse events were collected from first dose of study treatment until end of study treatment plus 60 days, up to maximum duration of 367 days.
Adverse Event Reporting Description	AE: Any sign or symptom that occurs during the study treatment plus up to 60 days post treatment
Arm/Group Title	Ofa + Benda (Arm A)	Benda (Arm B)	Optional Ofa	Ofa + Benda (Arm A) + Benda (Arm B) + Optional Ofa
Arm/Group Description	ofatumumab and bendamustine arm. Participants received up to 8 cycles of bendamustine (90 mg/m2) on Days 1,2 every 21 days with 12 doses of ofatumumab (1000 mg, Day 1 q21 days when with bendamustine and every 28 days	Bendamustine monotherapy. Participants received up to 8 cycles of bendamustine (120 mg/m2 on Days 1, 2 every 21 days	Eligible benda arm participants who were offered optional ofatumumab following disease progression	All participants in the Ofa + Benda arm and in the Benda only arm
All-Cause Mortality
	Ofa + Benda (Arm A)	Benda (Arm B)	Optional Ofa	Ofa + Benda (Arm A) + Benda (Arm B) + Optional Ofa
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	66/172 (38.37%)	71/170 (41.76%)	15/32 (46.88%)	137/342 (40.06%)
Serious Adverse Events
	Ofa + Benda (Arm A)	Benda (Arm B)	Optional Ofa	Ofa + Benda (Arm A) + Benda (Arm B) + Optional Ofa
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	72/172 (41.86%)	84/170 (49.41%)	8/32 (25.00%)	160/342 (46.78%)
Blood and lymphatic system disorders
Anaemia † 1	2/172 (1.16%)	10/170 (5.88%)	0/32 (0.00%)	12/342 (3.51%)
Aplastic anaemia † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Autoimmune haemolytic anaemia † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Febrile neutropenia † 1	8/172 (4.65%)	5/170 (2.94%)	2/32 (6.25%)	15/342 (4.39%)
Haemolytic anaemia † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Haemorrhagic anaemia † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Leukopenia † 1	1/172 (0.58%)	3/170 (1.76%)	0/32 (0.00%)	4/342 (1.17%)
Neutropenia † 1	6/172 (3.49%)	8/170 (4.71%)	0/32 (0.00%)	14/342 (4.09%)
Pancytopenia † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Thrombocytopenia † 1	2/172 (1.16%)	6/170 (3.53%)	0/32 (0.00%)	8/342 (2.34%)
Thrombocytopenic purpura † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Cardiac disorders
Acute coronary syndrome † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Atrial fibrillation † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Cardiac arrest † 1	0/172 (0.00%)	2/170 (1.18%)	0/32 (0.00%)	2/342 (0.58%)
Cardiac failure chronic † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Cardiac failure congestive † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Cardio-respiratory arrest † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Cardiopulmonary failure † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Coronary artery disease † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Left ventricular dysfunction † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Myocardial infarction † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Sinus tachycardia † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Supraventricular tachycardia † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Tachycardia † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Ventricular tachycardia † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Eye disorders
Optic atrophy † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Retinal artery occlusion † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Retinal haemorrhage † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Gastrointestinal disorders
Abdominal pain † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Colitis † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Diarrhoea † 1	1/172 (0.58%)	1/170 (0.59%)	0/32 (0.00%)	2/342 (0.58%)
Duodenal perforation † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Faecalith † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Gastrointestinal haemorrhage † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Nausea † 1	0/172 (0.00%)	2/170 (1.18%)	0/32 (0.00%)	2/342 (0.58%)
Small intestinal obstruction † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Stomatitis † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Vomiting † 1	2/172 (1.16%)	1/170 (0.59%)	0/32 (0.00%)	3/342 (0.88%)
General disorders
Asthenia † 1	1/172 (0.58%)	2/170 (1.18%)	0/32 (0.00%)	3/342 (0.88%)
Death † 1	3/172 (1.74%)	1/170 (0.59%)	0/32 (0.00%)	4/342 (1.17%)
Disease progression † 1	0/172 (0.00%)	1/170 (0.59%)	1/32 (3.13%)	2/342 (0.58%)
Fatigue † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
General physical health deterioration † 1	1/172 (0.58%)	2/170 (1.18%)	0/32 (0.00%)	3/342 (0.88%)
Malaise † 1	1/172 (0.58%)	2/170 (1.18%)	0/32 (0.00%)	3/342 (0.88%)
Mucosal inflammation † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Multiple organ dysfunction syndrome † 1	0/172 (0.00%)	2/170 (1.18%)	0/32 (0.00%)	2/342 (0.58%)
Pyrexia † 1	7/172 (4.07%)	9/170 (5.29%)	0/32 (0.00%)	16/342 (4.68%)
Systemic inflammatory response syndrome † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Hepatobiliary disorders
Drug-induced liver injury † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Hepatorenal syndrome † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Hyperbilirubinaemia † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Portal vein thrombosis † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Immune system disorders
Hypersensitivity † 1	0/172 (0.00%)	2/170 (1.18%)	0/32 (0.00%)	2/342 (0.58%)
Type IV hypersensitivity reaction † 1	0/172 (0.00%)	0/170 (0.00%)	1/32 (3.13%)	1/342 (0.29%)
Infections and infestations
Abdominal sepsis † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Acinetobacter bacteraemia † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Atypical pneumonia † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Bronchiolitis † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Bronchopulmonary aspergillosis † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Candida infection † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Cellulitis † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Clostridium difficile infection † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Cytomegalovirus chorioretinitis † 1	1/172 (0.58%)	1/170 (0.59%)	0/32 (0.00%)	2/342 (0.58%)
Cytomegalovirus infection † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Device related sepsis † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Dysentery † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Escherichia urinary tract infection † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Febrile infection † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Gastroenteritis † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Herpes ophthalmic † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Herpes zoster † 1	1/172 (0.58%)	4/170 (2.35%)	0/32 (0.00%)	5/342 (1.46%)
Herpes zoster disseminated † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Infective exacerbation of chronic obstructive airways disease † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Klebsiella sepsis † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Lower respiratory tract infection † 1	0/172 (0.00%)	2/170 (1.18%)	0/32 (0.00%)	2/342 (0.58%)
Lung infection † 1	3/172 (1.74%)	2/170 (1.18%)	0/32 (0.00%)	5/342 (1.46%)
Meningitis † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Neutropenic infection † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Oesophageal candidiasis † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Peritonitis † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Pharyngitis † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Pneumocystis jirovecii infection † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Pneumocystis jirovecii pneumonia † 1	0/172 (0.00%)	2/170 (1.18%)	1/32 (3.13%)	3/342 (0.88%)
Pneumonia † 1	10/172 (5.81%)	14/170 (8.24%)	1/32 (3.13%)	25/342 (7.31%)
Pneumonia cytomegaloviral † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Postoperative abscess † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Progressive multifocal leukoencephalopathy † 1	1/172 (0.58%)	1/170 (0.59%)	0/32 (0.00%)	2/342 (0.58%)
Pulmonary sepsis † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Respiratory tract infection † 1	2/172 (1.16%)	1/170 (0.59%)	0/32 (0.00%)	3/342 (0.88%)
Sepsis † 1	1/172 (0.58%)	2/170 (1.18%)	0/32 (0.00%)	3/342 (0.88%)
Septic shock † 1	1/172 (0.58%)	2/170 (1.18%)	0/32 (0.00%)	3/342 (0.88%)
Sinusitis † 1	1/172 (0.58%)	2/170 (1.18%)	0/32 (0.00%)	3/342 (0.88%)
Skin infection † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Spinal cord infection † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Staphylococcal sepsis † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Staphylococcal skin infection † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Subcutaneous abscess † 1	0/172 (0.00%)	0/170 (0.00%)	1/32 (3.13%)	1/342 (0.29%)
Tuberculosis † 1	1/172 (0.58%)	1/170 (0.59%)	0/32 (0.00%)	2/342 (0.58%)
Upper respiratory tract infection † 1	0/172 (0.00%)	2/170 (1.18%)	0/32 (0.00%)	2/342 (0.58%)
Urinary tract infection † 1	2/172 (1.16%)	0/170 (0.00%)	0/32 (0.00%)	2/342 (0.58%)
Urosepsis † 1	1/172 (0.58%)	1/170 (0.59%)	0/32 (0.00%)	2/342 (0.58%)
Varicella † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Injury, poisoning and procedural complications
Fall † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Femur fracture † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Hip fracture † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Jaw fracture † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Multiple fractures † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Multiple injuries † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Investigations
Cytomegalovirus test positive † 1	0/172 (0.00%)	2/170 (1.18%)	0/32 (0.00%)	2/342 (0.58%)
Neutrophil count decreased † 1	2/172 (1.16%)	0/170 (0.00%)	0/32 (0.00%)	2/342 (0.58%)
Oxygen saturation decreased † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Metabolism and nutrition disorders
Decreased appetite † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Dehydration † 1	0/172 (0.00%)	3/170 (1.76%)	0/32 (0.00%)	3/342 (0.88%)
Diabetes mellitus † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Failure to thrive † 1	2/172 (1.16%)	0/170 (0.00%)	0/32 (0.00%)	2/342 (0.58%)
Hypokalaemia † 1	0/172 (0.00%)	3/170 (1.76%)	0/32 (0.00%)	3/342 (0.88%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Pathological fracture † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia † 1	1/172 (0.58%)	1/170 (0.59%)	0/32 (0.00%)	2/342 (0.58%)
Adenocarcinoma gastric † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Adenocarcinoma pancreas † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Basal cell carcinoma † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Benign ovarian tumour † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Brain neoplasm † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Burkitt's lymphoma † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Colon cancer metastatic † 1	0/172 (0.00%)	0/170 (0.00%)	1/32 (3.13%)	1/342 (0.29%)
Diffuse large B-cell lymphoma † 1	1/172 (0.58%)	1/170 (0.59%)	0/32 (0.00%)	2/342 (0.58%)
Lung adenocarcinoma † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Lung neoplasm malignant † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Malignant melanoma † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Myelodysplastic syndrome † 1	2/172 (1.16%)	1/170 (0.59%)	0/32 (0.00%)	3/342 (0.88%)
Myelofibrosis † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Pancreatic carcinoma † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Transitional cell carcinoma † 1	2/172 (1.16%)	0/170 (0.00%)	0/32 (0.00%)	2/342 (0.58%)
Tumour haemorrhage † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Tumour pain † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Nervous system disorders
Cerebral haemorrhage † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Cerebrovascular accident † 1	1/172 (0.58%)	1/170 (0.59%)	0/32 (0.00%)	2/342 (0.58%)
Generalised tonic-clonic seizure † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Lethargy † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Paraparesis † 1	2/172 (1.16%)	0/170 (0.00%)	0/32 (0.00%)	2/342 (0.58%)
Status epilepticus † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Syncope † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Transient ischaemic attack † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Vascular encephalopathy † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Psychiatric disorders
Abnormal behaviour † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Confusional state † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Depression † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Renal and urinary disorders
Acute kidney injury † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Nephrolithiasis † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Renal failure † 1	1/172 (0.58%)	2/170 (1.18%)	0/32 (0.00%)	3/342 (0.88%)
Urinary tract inflammation † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Bronchiectasis † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Chronic obstructive pulmonary disease † 1	1/172 (0.58%)	2/170 (1.18%)	0/32 (0.00%)	3/342 (0.88%)
Dyspnoea † 1	1/172 (0.58%)	2/170 (1.18%)	0/32 (0.00%)	3/342 (0.88%)
Haemoptysis † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Pleural effusion † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Pneumonia aspiration † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Pneumonitis † 1	1/172 (0.58%)	4/170 (2.35%)	0/32 (0.00%)	5/342 (1.46%)
Productive cough † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Pulmonary embolism † 1	3/172 (1.74%)	1/170 (0.59%)	0/32 (0.00%)	4/342 (1.17%)
Pulmonary oedema † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Pulmonary thrombosis † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Respiratory distress † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Respiratory failure † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Skin and subcutaneous tissue disorders
Dermatitis † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Paraneoplastic pemphigus † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Stevens-Johnson syndrome † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Toxic epidermal necrolysis † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Urticaria † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Social circumstances
Loss of personal independence in daily activities † 1	0/172 (0.00%)	1/170 (0.59%)	0/32 (0.00%)	1/342 (0.29%)
Vascular disorders
Aortic aneurysm † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Aortic aneurysm rupture † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Circulatory collapse † 1	0/172 (0.00%)	0/170 (0.00%)	1/32 (3.13%)	1/342 (0.29%)
Embolism † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Hypertension † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Jugular vein thrombosis † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Lymphoedema † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
Subclavian vein thrombosis † 1	1/172 (0.58%)	0/170 (0.00%)	0/32 (0.00%)	1/342 (0.29%)
1 Term from vocabulary, MedDRA (19.0); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Ofa + Benda (Arm A)	Benda (Arm B)	Optional Ofa	Ofa + Benda (Arm A) + Benda (Arm B) + Optional Ofa
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	158/172 (91.86%)	162/170 (95.29%)	21/32 (65.63%)	320/342 (93.57%)
Blood and lymphatic system disorders
Anaemia † 1	31/172 (18.02%)	46/170 (27.06%)	0/32 (0.00%)	77/342 (22.51%)
Leukopenia † 1	25/172 (14.53%)	21/170 (12.35%)	1/32 (3.13%)	46/342 (13.45%)
Lymphopenia † 1	17/172 (9.88%)	17/170 (10.00%)	0/32 (0.00%)	34/342 (9.94%)
Neutropenia † 1	66/172 (38.37%)	74/170 (43.53%)	3/32 (9.38%)	141/342 (41.23%)
Thrombocytopenia † 1	30/172 (17.44%)	46/170 (27.06%)	1/32 (3.13%)	77/342 (22.51%)
Eye disorders
Vitreous floaters † 1	1/172 (0.58%)	0/170 (0.00%)	2/32 (6.25%)	3/342 (0.88%)
Gastrointestinal disorders
Abdominal pain † 1	9/172 (5.23%)	11/170 (6.47%)	1/32 (3.13%)	20/342 (5.85%)
Constipation † 1	29/172 (16.86%)	40/170 (23.53%)	4/32 (12.50%)	72/342 (21.05%)
Diarrhoea † 1	35/172 (20.35%)	40/170 (23.53%)	3/32 (9.38%)	75/342 (21.93%)
Dry mouth † 1	7/172 (4.07%)	9/170 (5.29%)	0/32 (0.00%)	16/342 (4.68%)
Dyspepsia † 1	9/172 (5.23%)	7/170 (4.12%)	0/32 (0.00%)	16/342 (4.68%)
Nausea † 1	62/172 (36.05%)	93/170 (54.71%)	5/32 (15.63%)	155/342 (45.32%)
Stomatitis † 1	6/172 (3.49%)	12/170 (7.06%)	1/32 (3.13%)	19/342 (5.56%)
Vomiting † 1	25/172 (14.53%)	40/170 (23.53%)	2/32 (6.25%)	66/342 (19.30%)
General disorders
Asthenia † 1	17/172 (9.88%)	27/170 (15.88%)	0/32 (0.00%)	44/342 (12.87%)
Chills † 1	9/172 (5.23%)	15/170 (8.82%)	1/32 (3.13%)	25/342 (7.31%)
Fatigue † 1	41/172 (23.84%)	59/170 (34.71%)	5/32 (15.63%)	101/342 (29.53%)
Influenza like illness † 1	9/172 (5.23%)	4/170 (2.35%)	0/32 (0.00%)	13/342 (3.80%)
Malaise † 1	3/172 (1.74%)	12/170 (7.06%)	0/32 (0.00%)	15/342 (4.39%)
Mucosal inflammation † 1	9/172 (5.23%)	14/170 (8.24%)	1/32 (3.13%)	24/342 (7.02%)
Oedema peripheral † 1	9/172 (5.23%)	14/170 (8.24%)	0/32 (0.00%)	23/342 (6.73%)
Pyrexia † 1	33/172 (19.19%)	44/170 (25.88%)	2/32 (6.25%)	78/342 (22.81%)
Infections and infestations
Bronchitis † 1	19/172 (11.05%)	11/170 (6.47%)	0/32 (0.00%)	30/342 (8.77%)
Herpes zoster † 1	9/172 (5.23%)	10/170 (5.88%)	1/32 (3.13%)	20/342 (5.85%)
Nasopharyngitis † 1	27/172 (15.70%)	14/170 (8.24%)	1/32 (3.13%)	42/342 (12.28%)
Oral herpes † 1	9/172 (5.23%)	10/170 (5.88%)	1/32 (3.13%)	19/342 (5.56%)
Sinusitis † 1	10/172 (5.81%)	7/170 (4.12%)	0/32 (0.00%)	17/342 (4.97%)
Upper respiratory tract infection † 1	12/172 (6.98%)	15/170 (8.82%)	5/32 (15.63%)	29/342 (8.48%)
Urinary tract infection † 1	11/172 (6.40%)	7/170 (4.12%)	3/32 (9.38%)	21/342 (6.14%)
Injury, poisoning and procedural complications
Infusion related reaction † 1	19/172 (11.05%)	2/170 (1.18%)	4/32 (12.50%)	25/342 (7.31%)
Investigations
Neutrophil count decreased † 1	13/172 (7.56%)	13/170 (7.65%)	0/32 (0.00%)	26/342 (7.60%)
Platelet count decreased † 1	12/172 (6.98%)	14/170 (8.24%)	0/32 (0.00%)	26/342 (7.60%)
Weight decreased † 1	11/172 (6.40%)	20/170 (11.76%)	0/32 (0.00%)	31/342 (9.06%)
White blood cell count decreased † 1	11/172 (6.40%)	9/170 (5.29%)	0/32 (0.00%)	20/342 (5.85%)
Metabolism and nutrition disorders
Decreased appetite † 1	24/172 (13.95%)	44/170 (25.88%)	2/32 (6.25%)	69/342 (20.18%)
Diabetes mellitus † 1	1/172 (0.58%)	0/170 (0.00%)	2/32 (6.25%)	3/342 (0.88%)
Hyperglycaemia † 1	9/172 (5.23%)	8/170 (4.71%)	0/32 (0.00%)	17/342 (4.97%)
Hyperkalaemia † 1	0/172 (0.00%)	1/170 (0.59%)	2/32 (6.25%)	3/342 (0.88%)
Hypokalaemia † 1	11/172 (6.40%)	15/170 (8.82%)	1/32 (3.13%)	27/342 (7.89%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	13/172 (7.56%)	12/170 (7.06%)	0/32 (0.00%)	25/342 (7.31%)
Back pain † 1	13/172 (7.56%)	5/170 (2.94%)	2/32 (6.25%)	20/342 (5.85%)
Musculoskeletal pain † 1	0/172 (0.00%)	5/170 (2.94%)	2/32 (6.25%)	7/342 (2.05%)
Myalgia † 1	4/172 (2.33%)	9/170 (5.29%)	2/32 (6.25%)	15/342 (4.39%)
Pain in extremity † 1	11/172 (6.40%)	8/170 (4.71%)	0/32 (0.00%)	19/342 (5.56%)
Nervous system disorders
Dizziness † 1	14/172 (8.14%)	7/170 (4.12%)	1/32 (3.13%)	22/342 (6.43%)
Dysgeusia † 1	9/172 (5.23%)	20/170 (11.76%)	0/32 (0.00%)	29/342 (8.48%)
Headache † 1	31/172 (18.02%)	21/170 (12.35%)	4/32 (12.50%)	56/342 (16.37%)
Psychiatric disorders
Insomnia † 1	15/172 (8.72%)	8/170 (4.71%)	3/32 (9.38%)	26/342 (7.60%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	38/172 (22.09%)	27/170 (15.88%)	6/32 (18.75%)	68/342 (19.88%)
Dyspnoea † 1	14/172 (8.14%)	21/170 (12.35%)	4/32 (12.50%)	38/342 (11.11%)
Oropharyngeal pain † 1	10/172 (5.81%)	3/170 (1.76%)	1/32 (3.13%)	14/342 (4.09%)
Skin and subcutaneous tissue disorders
Dry skin † 1	4/172 (2.33%)	4/170 (2.35%)	2/32 (6.25%)	10/342 (2.92%)
Erythema † 1	7/172 (4.07%)	4/170 (2.35%)	2/32 (6.25%)	12/342 (3.51%)
Pruritus † 1	24/172 (13.95%)	12/170 (7.06%)	4/32 (12.50%)	40/342 (11.70%)
Rash † 1	33/172 (19.19%)	15/170 (8.82%)	2/32 (6.25%)	50/342 (14.62%)
Urticaria † 1	13/172 (7.56%)	1/170 (0.59%)	4/32 (12.50%)	18/342 (5.26%)
Vascular disorders
Hypertension † 1	10/172 (5.81%)	6/170 (3.53%)	5/32 (15.63%)	21/342 (6.14%)
Hypotension † 1	9/172 (5.23%)	6/170 (3.53%)	1/32 (3.13%)	16/342 (4.68%)
Phlebitis † 1	6/172 (3.49%)	10/170 (5.88%)	0/32 (0.00%)	16/342 (4.68%)
1 Term from vocabulary, MedDRA (19.0); † Indicates events were collected by systematic assessment

Limitations and Caveats

As the primary endpoint of the study was not met, secondary efficacy endpoints were not fully tested. The data being reported is for information only and not intended to be inferential.

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.

The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of pooled data (i.e.,data from all sites) in clinical trial or disclosure of trial results in their entirety.

Results Point of Contact

• Name/Title: Study Director
• Organization: Novartis Pharmaceuticals
• Phone: 862-778-8300
• EMail: novartis.email@novartis.com

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

Rummel MJ, Janssens A, MacDonald D, Keating MM, Zaucha JM, Davis J, Lasher J, Babanrao Pisal C, Izquierdo M, Friedberg JW. A phase 3, randomized study of ofatumumab combined with bendamustine in rituximab-refractory iNHL (COMPLEMENT A + B study). Br J Haematol. 2021 Jun;193(6):1123-1133. doi: 10.1111/bjh.17420. Epub 2021 May 10.

• Responsible Party: Novartis ( Novartis Pharmaceuticals )
• ClinicalTrials.gov Identifier: NCT01077518
• Other Study ID Numbers: 110918; 2008-004177-17 ( EudraCT Number ); COMB157E2301 ( Other Identifier: Novartis )
• First Submitted: February 25, 2010
• First Posted: March 1, 2010
• Results First Submitted: December 24, 2019
• Results First Posted: March 27, 2020
• Last Update Posted: March 27, 2020