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

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ClinicalTrials.gov Identifier: NCT01077518
Recruitment Status : Terminated (The study was terminated early as it did not meet the Primary efficacy objective after primary analysis.)
First Posted : March 1, 2010
Results First Posted : March 27, 2020
Last Update Posted : March 27, 2020
Sponsor:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ofa + Benda (Arm A) Benda (Arm B) Optional Ofa
Hide 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
Arm/Group Title Ofa + Benda (Arm A) Benda (Arm B) Total
Hide 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
Hide 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
1.Primary Outcome
Title Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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)
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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)
Hide Description A summary by responders and non-responders
Time Frame From randomization up to about 67.5 months
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT: The ITT population included subjects who were randomized in the study.
Arm/Group Title Optional Ofa
Hide 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)
Hide 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
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Hide 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)
Hide 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
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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+)
Hide 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
Hide Outcome Measure Data
Hide 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)
Hide 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
Hide Description The number of participants with positive and negative baseline HACA results
Time Frame At Baseline and Cycle 1 day 1
Hide Outcome Measure Data
Hide 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)
Hide 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
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
Hide 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%) 
Hide 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
Hide 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
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.
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
EMail: novartis.email@novartis.com
Layout table for additonal information
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