Trial Outcomes & Findings for A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN) (NCT NCT01059630)

NCT ID: NCT01059630

Last Updated: 2020-01-13

Results Overview

PD was assessed by an IRC according to the modified response criteria for indolent Non-Hodgkin's Lymphoma (iNHL) (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50 percent (%) increase from nadir in the sum of product diameter (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (example: splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of less than (\<) 1.0 cm must increase by greater than or equal to (≥) 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node greater than (\>) 1 cm in its short axis.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 413 participants
• Primary outcome timeframe: Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])
• Results posted on: 2020-01-13

Participant Flow

Participant milestones

Measure	Bendamustine Alone Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Study STARTED	209	204
Overall Study COMPLETED	82	101
Overall Study NOT COMPLETED	127	103

Reasons for withdrawal

Measure	Bendamustine Alone Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Study Death	100	84
Overall Study Lost to Follow-up	4	1
Overall Study Physician Decision	2	4
Overall Study Withdrawal by Subject	21	14

Baseline Characteristics

A Study to Investigate the Efficacy and Safety of Bendamustine Compared With Bendamustine+Obinutuzumab (GA101) in Participants With Rituximab-Refractory, Indolent Non-Hodgkin's Lymphoma (GADOLIN)

Baseline characteristics by cohort

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).	Total n=413 Participants Total of all reporting groups
Age, Continuous	61.9 Years STANDARD_DEVIATION 11.5 • n=5 Participants	62.0 Years STANDARD_DEVIATION 11.3 • n=7 Participants	61.9 Years STANDARD_DEVIATION 11.4 • n=5 Participants
Sex: Female, Male Female	87 Participants n=5 Participants	88 Participants n=7 Participants	175 Participants n=5 Participants
Sex: Female, Male Male	122 Participants n=5 Participants	116 Participants n=7 Participants	238 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	174 Participants n=5 Participants	183 Participants n=7 Participants	357 Participants n=5 Participants
Race/Ethnicity, Customized Not Stated	30 Participants n=5 Participants	15 Participants n=7 Participants	45 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Unknown	19 Participants n=5 Participants	12 Participants n=7 Participants	31 Participants n=5 Participants
Race/Ethnicity, Customized White	181 Participants n=5 Participants	180 Participants n=7 Participants	361 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cycle [Cy] 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])

Population: ITT population.

PD was assessed by an IRC according to the modified response criteria for indolent Non-Hodgkin's Lymphoma (iNHL) (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 centimeters (cm) in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50 percent (%) increase from nadir in the sum of product diameter (SPD) of any previously involved nodes, or in a single involved node, or the size of other lesions (example: splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of less than (<) 1.0 cm must increase by greater than or equal to (≥) 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node greater than (>) 1 cm in its short axis.

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Number of Participants With Progressive Disease (PD) as Assessed by Independent Review Committee (IRC) or Death	125 participants	87 participants

PRIMARY outcome

Timeframe: Baseline until PD or death, whichever occurred first (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1, then every 3 months up to 2 years and every 6 months for next 2 years [up to 4.5 years overall])

Population: ITT population.

PFS was defined as the time from randomization to the first occurrence of PD or death as assessed by an IRC according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% confidence interval (CI) for median was computed using the method of Brookmeyer and Crowley.

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Progression-Free Survival (PFS) as Assessed by IRC	14.1 months Interval 11.7 to 16.6	29.2 months Interval 20.5 to Upper limit was not reached due to low number of participants with events.

SECONDARY outcome

Timeframe: Baseline until PD or death, whichever occurred first (up to 8.5 years overall))

Population: ITT population.

PD was assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007). PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis.

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Number of Participants With PD or Death as Assessed by Investigator	152 participants	132 participants

SECONDARY outcome

Timeframe: Baseline until PD or death, whichever occurred first (up to 8.5 years overall)

Population: ITT population.

PFS was defined as the time from randomization to the first occurrence of PD as assessed by an investigator according to the modified response criteria for iNHL (Modified Cheson et al, 2007), or death from any cause on study. PD was defined as appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules). To be considered PD, a lymph node with a diameter of the short axis of <1.0 cm must increase by ≥ 50% and to a size of 1.5 multiplied by 1.5 cm or more than 1.5 cm in the long axis; at least a 50% increase in the longest diameter of any single previously identified node >1 cm in its short axis. PFS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
PFS as Assessed by Investigator	14.1 months Interval 12.6 to 16.2	25.8 months Interval 20.1 to 36.5

SECONDARY outcome

Timeframe: Baseline until PD or death, whichever occurred first (up to approximately 5 years)

Population: ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.

Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015.

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Percentage of Participants With Objective Response as Assessed by IRC	77.5 percentage of participants Interval 71.24 to 82.98	75.5 percentage of participants Interval 69.0 to 81.23

SECONDARY outcome

Timeframe: Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)

Population: ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.

Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Percentage of Participants With Objective Response as Assessed by Investigator	83.3 percentage of participants Interval 77.49 to 88.05	82.4 percentage of participants Interval 76.42 to 87.32

SECONDARY outcome

Timeframe: Baseline until PD or death, whichever occurred first (up to approximately 5 years)

Population: ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.

BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan & no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions (e.g., splenic or hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015.

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC PD	5.7 percentage of participants Interval 3.0 to 9.81	4.9 percentage of participants Interval 2.38 to 8.83
Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC Unable to evaluate	1.0 percentage of participants Interval 0.12 to 3.41	1.0 percentage of participants Interval 0.12 to 3.5
Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC PR	60.3 percentage of participants Interval 53.31 to 66.97	59.3 percentage of participants Interval 52.23 to 66.12
Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC SD	12.0 percentage of participants Interval 7.89 to 17.15	13.7 percentage of participants Interval 9.32 to 19.22
Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC Missing	3.8 percentage of participants Interval 1.67 to 7.4	4.9 percentage of participants Interval 2.38 to 8.83
Percentage of Participants With Best Overall Response (BOR) as Assessed by IRC CR	17.2 percentage of participants Interval 12.37 to 23.04	16.2 percentage of participants Interval 11.4 to 21.96

SECONDARY outcome

Timeframe: Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)

Population: ITT population. Here, number of participants analyzed signified those participants who had at least one post-baseline assessment.

BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain the criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator Missing	3.8 percentage of participants Interval 1.67 to 7.4	4.4 percentage of participants Interval 2.04 to 8.21
Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator CR	21.5 percentage of participants Interval 16.16 to 27.73	23.5 percentage of participants Interval 17.89 to 29.96
Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator PR	61.7 percentage of participants Interval 54.76 to 68.34	58.8 percentage of participants Interval 51.74 to 65.65
Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator SD	6.7 percentage of participants Interval 3.71 to 10.98	6.4 percentage of participants Interval 3.44 to 10.65
Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator PD	4.8 percentage of participants Interval 2.32 to 8.62	6.4 percentage of participants Interval 3.44 to 10.65
Percentage of Participants With Best Overall Response (BOR) as Assessed by Investigator Unable to evaluate	1.4 percentage of participants Interval 0.3 to 4.14	0.5 percentage of participants Interval 0.01 to 2.7

SECONDARY outcome

Timeframe: Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)

Population: ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.

BOR observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease & disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan & no new sites; no increase in size of other nodes, liver or spleen; with exception of splenic & hepatic nodules, involvement of other organs is usually assessable & no measurable disease should be present, SD: Failing to attain criteria needed for a CR/PR, but not fulfilling those for PD, PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or size of other lesions (e.g., splenic/hepatic nodules). IRC review was performed up clinical cutoff date of to 1 May 2015.

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC CR	12.0 percentage of participants Interval 7.93 to 17.23	11.8 percentage of participants Interval 7.69 to 17.0
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC PR	52.4 percentage of participants Interval 45.38 to 59.35	54.9 percentage of participants Interval 47.8 to 61.86
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC SD	10.1 percentage of participants Interval 6.36 to 15.02	11.8 percentage of participants Interval 7.69 to 17.0
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC PD	10.6 percentage of participants Interval 6.75 to 15.58	8.8 percentage of participants Interval 5.31 to 13.59
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC Unable to Evaluate	2.9 percentage of participants Interval 1.07 to 6.17	2.0 percentage of participants Interval 0.54 to 4.94
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by IRC Missing	12.0 percentage of participants Interval 7.93 to 17.23	10.8 percentage of participants Interval 6.88 to 15.87

SECONDARY outcome

Timeframe: Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)

Population: ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.

BOR: best response for a participant, observed during assessment period according to modified response criteria for iNHL (Modified Cheson et al, 2007). CR: complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present, SD: Failing to attain criteria needed for a CR or PR, but not fulfilling those for PD, PD: appearance of any new lesion more than 1.5 cm in any axis during or at the end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in the SPD of any previously involved nodes, or in a single involved node, or the size of other lesions (e.g., splenic or hepatic nodules).

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator Unable to Evaluate	2.9 percentage of participants Interval 1.06 to 6.14	0.5 percentage of participants Interval 0.01 to 2.7
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator CR	15.8 percentage of participants Interval 11.12 to 21.45	17.2 percentage of participants Interval 12.25 to 23.04
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator PR	53.1 percentage of participants Interval 46.1 to 60.03	60.3 percentage of participants Interval 53.23 to 67.06
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator SD	4.3 percentage of participants Interval 1.99 to 8.02	3.9 percentage of participants Interval 1.71 to 7.58
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator PD	12.0 percentage of participants Interval 7.89 to 17.15	9.3 percentage of participants Interval 5.7 to 14.16
Percentage of Participants With BOR at the End of Induction Treatment as Assessed by Investigator Missing	12.0 percentage of participants Interval 7.89 to 17.15	8.8 percentage of participants Interval 5.31 to 13.59

SECONDARY outcome

Timeframe: Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)

Population: ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.

Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present. IRC review was performed up clinical cutoff date of to 1 May 2015.

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by IRC	64.4 percentage of participants Interval 57.51 to 70.92	66.7 percentage of participants Interval 59.75 to 73.1

SECONDARY outcome

Timeframe: Baseline until end of induction treatment (assessed at baseline, 14 days prior to Cy 4 Day 1 [1 Cy=28days], 28-42 days after Cy 6 Day 1)

Population: ITT population. Here, number of participants analyzed signified those participants who had reached the end of induction treatment response assessment.

Objective response was defined as having CR or PR as assessed according to the modified response criteria for iNHL (Modified Cheson et al, 2007). CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to tumors measured by a baseline scan and no new sites; no increase in the size of the other nodes, liver, or spleen; with the exception of splenic and hepatic nodules, involvement of other organs is usually assessable and no measurable disease should be present.

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Percentage of Participants With Objective Response at the End of Induction Treatment as Assessed by Investigator	68.9 percentage of participants Interval 62.15 to 75.11	77.5 percentage of participants Interval 71.09 to 82.99

SECONDARY outcome

Timeframe: Baseline until PD or death, whichever occurred first (up to approximately 5 years)

Population: ITT population. Here, number of participants analyzed signified those participants who had objective response at any time during the study.

DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable evidence of disease & disease-related symptoms if present before therapy; liver, spleen returned to normal size; if bone marrow involved by lymphoma before treatment, infiltrate must be cleared on repeat bone marrow biopsy. PR: at least 50% measurable disease regressed vs. to baseline scan and no new sites; no increase in size of other nodes/liver/spleen, exception: splenic, hepatic nodules; other organs involved is usually assessable; no measurable disease present. PD: any new lesion >1.5 cm in any axis appear during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR estimated using Kaplan-Meier method. IRC review performed up to clinical cutoff date 1 May 2015.

Outcome measures

Measure	Bendamustine Alone n=165 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=158 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Duration of Response (DoR) as Assessed by IRC	12.7 months Interval 10.4 to 14.1	38.5 months Interval 25.4 to Upper limit of 95% confidence interval could not be reached due to low number of participants with events.

SECONDARY outcome

Timeframe: Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)

Population: ITT population. Here, number of participants analyzed signified those participants who had objective response at any time during the study.

DoR: time from first objective response of CR/PR to first occurrence of PD/relapse/death from any cause. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy; liver, spleen returned to normal size (if enlarged at baseline); if bone marrow was involved by lymphoma prior to treatment, infiltrate must have cleared on repeat bone marrow biopsy. PR: at least 50% regression of measurable disease compared to baseline scan and no new sites; no increase in size of other nodes, liver, or spleen; with exception of splenic, hepatic nodules; involvement of other organs is usually assessable; no presence of measurable disease. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least 50% increase from nadir in SPD of any previously involved nodes, or in single involved node, or size of other lesions. DoR was estimated using Kaplan-Meier method.

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Duration of Response (DoR) as Assessed by Investigator	12.7 months Interval 11.1 to 15.5	32.3 months Interval 20.8 to 39.0

SECONDARY outcome

Timeframe: Baseline until PD or death, whichever occurred first (up to approximately 5 years)

Population: ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR.

DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015.

Outcome measures

Measure	Bendamustine Alone n=37 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=46 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Disease-Free Survival (DFS) in Participants With CR as Assessed by IRC	13.2 months Interval 8.5 to Upper limit of 95% confidence interval could not be estimated due to low number of participants with events.	NA months Median and 95% confidence interval could not be estimated due to low number of participants with events.

SECONDARY outcome

Timeframe: Baseline until PD or death, whichever occurred first (up to approximately 8.5 years)

Population: ITT population. Here, number of participants analyzed signified those participants who had an objective response of CR.

DFS was defined as the time from the first occurrence of a documented CR until progression on the basis of the IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]) or death from any cause on study. CR: Complete disappearance of all detectable clinical evidence of disease and disease-related symptoms if present prior to therapy, liver and spleen have returned to normal size (if enlarged at baseline), If the bone marrow was involved by lymphoma prior to treatment, the infiltrate must have cleared on repeat bone marrow biopsy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. DFS was estimated using Kaplan-Meier method.

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Disease-Free Survival (DFS) in Participants With CR as Assessed by Investigator	20.0 months Interval 8.6 to 31.0	36.0 months Interval 26.6 to 68.2

SECONDARY outcome

Timeframe: Baseline until PD or death, whichever occurred first (up to approximately 5 years)

Population: ITT population.

EFS was defined as the time between the date of randomization and the date of PD/relapse based on IRC assessments (as per modified response criteria for iNHL [Modified Cheson et al, 2007]), death from any cause on study, or start of a new anti-lymphoma therapy. PD: appearance of any new lesion >1.5 cm in any axis during or at end of therapy, even if other lesions are decreasing in size; at least a 50% increase from nadir in SPD of any previously involved nodes, or in a single involved node, or size of other lesions. EFS was estimated using Kaplan-Meier method. IRC review was performed up clinical cutoff date of to 1 May 2015.

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Event-free Survival (EFS) as Assessed by IRC	13.7 months Interval 11.4 to 15.5	25.3 months Interval 13.9 to 35.0

SECONDARY outcome

Timeframe: Baseline until death (up to 8.5 years overall)

Population: ITT population.

Outcome measures

Measure	Bendamustine Alone n=203 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Percentage of Participants Who Died	49.3 percentage of participants	41.2 percentage of participants

SECONDARY outcome

Timeframe: Baseline until death (up to 8.5 years overall)

Population: ITT population.

OS was defined as the time between the date of randomization and the date of death from any cause. OS was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley.

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Overall Survival (OS)	65.6 months Interval 48.5 to 87.8	88.3 months Interval 71.1 to Data could not be estimated due to higher (\>50%) number of censored participants.

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24

Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point.

The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Physical Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for physical well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better participant-reported outcome (PRO)/quality of life (QoL). In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

Outcome measures

Measure	Bendamustine Alone n=187 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=187 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Follow-up Month 16	-0.10 units on a scale Standard Deviation 3.49	1.31 units on a scale Standard Deviation 3.68
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Follow-up Month 12	0.26 units on a scale Standard Deviation 4.02	0.74 units on a scale Standard Deviation 4.24
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score Baseline	22.58 units on a scale Standard Deviation 5.23	22.76 units on a scale Standard Deviation 4.61
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Cycle 3 Day 1	-1.56 units on a scale Standard Deviation 5.49	-0.69 units on a scale Standard Deviation 4.06
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Cycle 4 Day 1	-6.80 units on a scale Standard Deviation 4.21	-3.00 units on a scale Standard Deviation 2.83
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Cycle 5 Day 1	-1.82 units on a scale Standard Deviation 5.06	-0.72 units on a scale Standard Deviation 4.16
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at End of Induction Treatment	-1.00 units on a scale Standard Deviation 5.14	-0.61 units on a scale Standard Deviation 4.62
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Follow-up Month 2	0.62 units on a scale Standard Deviation 5.14	0.58 units on a scale Standard Deviation 4.45
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Follow-up Month 4	0.53 units on a scale Standard Deviation 4.58	0.88 units on a scale Standard Deviation 4.47
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Follow-up Month 6	0.29 units on a scale Standard Deviation 3.74	0.91 units on a scale Standard Deviation 3.82
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Follow-up Month 8	-0.01 units on a scale Standard Deviation 3.53	0.87 units on a scale Standard Deviation 3.96
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Follow-up Month 10	0.06 units on a scale Standard Deviation 4.16	0.56 units on a scale Standard Deviation 3.81
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Follow-up Month 14	0.03 units on a scale Standard Deviation 4.14	0.71 units on a scale Standard Deviation 3.94
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Follow-up Month 18	-0.22 units on a scale Standard Deviation 3.64	0.92 units on a scale Standard Deviation 3.99
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Follow-up Month 20	-0.36 units on a scale Standard Deviation 3.70	0.74 units on a scale Standard Deviation 3.69
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Follow-up Month 22	-0.25 units on a scale Standard Deviation 3.93	0.40 units on a scale Standard Deviation 4.47
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Follow-up Month 24	-0.77 units on a scale Standard Deviation 4.16	0.52 units on a scale Standard Deviation 4.42
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Final Follow-up	0.16 units on a scale Standard Deviation 4.17	0.22 units on a scale Standard Deviation 4.47
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Extension Follow-up Month 6	0.36 units on a scale Standard Deviation 3.48	0.57 units on a scale Standard Deviation 4.71
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Extension Follow-up Month 18	0.80 units on a scale Standard Deviation 2.54	1.19 units on a scale Standard Deviation 4.98
Change From Baseline (CFB) in Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)-Physical Well Being Sub-scale Score CFB at Extension Follow-up Month 24	1.53 units on a scale Standard Deviation 5.96	0.56 units on a scale Standard Deviation 5.26

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24

Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point.

The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Social/family Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for social/family well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

Outcome measures

Measure	Bendamustine Alone n=186 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=191 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Follow-up Month 6	0.05 units on a scale Standard Deviation 4.46	-0.08 units on a scale Standard Deviation 4.64
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score Baseline	22.04 units on a scale Standard Deviation 5.65	22.14 units on a scale Standard Deviation 5.51
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Cycle 3 Day 1	-0.21 units on a scale Standard Deviation 3.59	-0.10 units on a scale Standard Deviation 3.87
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Cycle 4 Day 1	-1.00 units on a scale Standard Deviation 3.67	3.11 units on a scale Standard Deviation 2.83
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Cycle 5 Day 1	-0.34 units on a scale Standard Deviation 4.32	-0.34 units on a scale Standard Deviation 4.33
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at End of Induction Treatment	-0.65 units on a scale Standard Deviation 5.21	-0.88 units on a scale Standard Deviation 3.60
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Follow-up Month 2	-0.02 units on a scale Standard Deviation 4.83	-0.57 units on a scale Standard Deviation 5.37
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Follow-up Month 4	0.27 units on a scale Standard Deviation 4.65	-0.26 units on a scale Standard Deviation 5.02
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Follow-up Month 8	-0.68 units on a scale Standard Deviation 3.67	-0.37 units on a scale Standard Deviation 4.99
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Follow-up Month 10	0.56 units on a scale Standard Deviation 5.00	0.13 units on a scale Standard Deviation 5.14
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Follow-up Month 12	0.06 units on a scale Standard Deviation 5.89	-0.47 units on a scale Standard Deviation 5.64
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Follow-up Month 14	0.56 units on a scale Standard Deviation 3.28	-0.03 units on a scale Standard Deviation 4.16
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Follow-up Month 16	0.36 units on a scale Standard Deviation 6.79	-0.15 units on a scale Standard Deviation 5.28
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Follow-up Month 18	0.44 units on a scale Standard Deviation 6.23	0.04 units on a scale Standard Deviation 5.35
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Follow-up Month 20	-0.66 units on a scale Standard Deviation 4.28	0.00 units on a scale Standard Deviation 5.75
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Follow-up Month 22	0.29 units on a scale Standard Deviation 7.12	-0.50 units on a scale Standard Deviation 5.02
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Follow-up Month 24	-1.29 units on a scale Standard Deviation 3.91	-0.41 units on a scale Standard Deviation 5.24
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Final Follow-up	-0.19 units on a scale Standard Deviation 4.91	-0.52 units on a scale Standard Deviation 5.56
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Extension Follow-up Month 6	-0.35 units on a scale Standard Deviation 2.49	-0.16 units on a scale Standard Deviation 4.92
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Extension Follow-up Month 18	-0.15 units on a scale Standard Deviation 2.92	0.71 units on a scale Standard Deviation 5.26
CFB in FACT-Lym-Social/Family Well-being Sub-scale Score CFB at Extension Follow-up Month 24	-0.41 units on a scale Standard Deviation 3.18	0.44 units on a scale Standard Deviation 5.02

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24

Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point.

The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Emotional Well-being sub-scale includes 6 items measured on 0-4 point scale. The total score for emotional well-being sub-scale is sum of each 6 items (range: 0-24). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

Outcome measures

Measure	Bendamustine Alone n=189 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=193 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at End of Induction Treatment	0.53 units on a scale Standard Deviation 3.57	0.59 units on a scale Standard Deviation 4.03
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Cycle 5 Day 1	0.37 units on a scale Standard Deviation 3.08	0.50 units on a scale Standard Deviation 3.52
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Follow-up Month 4	1.34 units on a scale Standard Deviation 3.54	0.95 units on a scale Standard Deviation 3.51
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Follow-up Month 8	0.26 units on a scale Standard Deviation 3.35	0.97 units on a scale Standard Deviation 3.34
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Follow-up Month 10	0.69 units on a scale Standard Deviation 3.31	1.32 units on a scale Standard Deviation 3.23
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Follow-up Month 22	0.18 units on a scale Standard Deviation 2.81	0.97 units on a scale Standard Deviation 3.79
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Follow-up Month 24	0.06 units on a scale Standard Deviation 3.20	1.12 units on a scale Standard Deviation 3.78
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Extension Follow-up Month 24	1.04 units on a scale Standard Deviation 4.16	0.97 units on a scale Standard Deviation 4.36
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Follow-up Month 16	0.13 units on a scale Standard Deviation 3.87	1.04 units on a scale Standard Deviation 3.69
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score Baseline	17.38 units on a scale Standard Deviation 4.45	17.81 units on a scale Standard Deviation 4.33
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Cycle 3 Day 1	0.61 units on a scale Standard Deviation 3.04	0.78 units on a scale Standard Deviation 3.14
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Cycle 4 Day 1	-0.60 units on a scale Standard Deviation 3.85	3.40 units on a scale Standard Deviation 4.42
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Follow-up Month 2	0.66 units on a scale Standard Deviation 3.89	0.67 units on a scale Standard Deviation 3.83
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Follow-up Month 18	0.42 units on a scale Standard Deviation 3.36	1.00 units on a scale Standard Deviation 3.38
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Follow-up Month 20	-0.43 units on a scale Standard Deviation 2.90	0.94 units on a scale Standard Deviation 4.28
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Follow-up Month 6	0.89 units on a scale Standard Deviation 3.57	0.96 units on a scale Standard Deviation 3.44
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Final Follow-up	0.38 units on a scale Standard Deviation 3.77	0.34 units on a scale Standard Deviation 4.37
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Extension Follow-up Month 6	-0.44 units on a scale Standard Deviation 3.26	0.39 units on a scale Standard Deviation 3.99
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Extension Follow-up Month 18	-0.08 units on a scale Standard Deviation 3.80	0.75 units on a scale Standard Deviation 3.85
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Follow-up Month 12	-0.07 units on a scale Standard Deviation 3.88	0.95 units on a scale Standard Deviation 3.29
CFB in FACT-Lym-Emotional Well-Being Sub-scale Score CFB at Follow-up Month 14	0.46 units on a scale Standard Deviation 3.22	1.07 units on a scale Standard Deviation 3.82

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24

Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point.

The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Functional Well-being sub-scale includes 7 items measured on 0-4 point scale. The total score for functional well-being sub-scale is sum of each 7 items (range: 0-28). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

Outcome measures

Measure	Bendamustine Alone n=189 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=196 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Cycle 3 Day 1	-0.54 units on a scale Standard Deviation 4.65	0.38 units on a scale Standard Deviation 4.66
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Follow-up Month 2	0.31 units on a scale Standard Deviation 5.27	0.65 units on a scale Standard Deviation 5.38
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Follow-up Month 12	0.18 units on a scale Standard Deviation 5.59	1.78 units on a scale Standard Deviation 6.04
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Extension Follow-up Month 6	1.01 units on a scale Standard Deviation 3.51	0.85 units on a scale Standard Deviation 6.65
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Extension Follow-up Month 18	0.96 units on a scale Standard Deviation 4.51	1.90 units on a scale Standard Deviation 6.50
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Follow-up Month 4	0.24 units on a scale Standard Deviation 5.11	1.31 units on a scale Standard Deviation 5.86
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Follow-up Month 6	0.95 units on a scale Standard Deviation 4.58	1.26 units on a scale Standard Deviation 5.08
CFB in FACT-Lym-Functional Well-Being Sub-scale Score Baseline	17.98 units on a scale Standard Deviation 6.31	17.90 units on a scale Standard Deviation 6.08
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Cycle 4 Day 1	-0.80 units on a scale Standard Deviation 2.28	1.78 units on a scale Standard Deviation 4.91
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Cycle 5 Day 1	-0.71 units on a scale Standard Deviation 5.04	0.67 units on a scale Standard Deviation 5.35
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at End of Induction Treatment	-0.50 units on a scale Standard Deviation 5.50	0.00 units on a scale Standard Deviation 5.25
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Follow-up Month 8	-0.27 units on a scale Standard Deviation 4.38	0.92 units on a scale Standard Deviation 5.45
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Follow-up Month 10	1.09 units on a scale Standard Deviation 4.25	1.00 units on a scale Standard Deviation 5.52
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Follow-up Month 14	1.16 units on a scale Standard Deviation 4.27	1.22 units on a scale Standard Deviation 4.84
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Follow-up Month 16	0.91 units on a scale Standard Deviation 3.97	1.69 units on a scale Standard Deviation 5.95
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Follow-up Month 18	0.21 units on a scale Standard Deviation 4.12	1.84 units on a scale Standard Deviation 5.77
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Follow-up Month 20	-0.27 units on a scale Standard Deviation 4.90	1.43 units on a scale Standard Deviation 6.14
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Follow-up Month 22	-0.32 units on a scale Standard Deviation 5.70	0.82 units on a scale Standard Deviation 5.00
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Follow-up Month 24	-0.96 units on a scale Standard Deviation 4.36	0.98 units on a scale Standard Deviation 5.87
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Final Follow-up	-0.08 units on a scale Standard Deviation 4.94	0.50 units on a scale Standard Deviation 6.19
CFB in FACT-Lym-Functional Well-Being Sub-scale Score CFB at Extension Follow-up Month 24	2.22 units on a scale Standard Deviation 3.34	2.62 units on a scale Standard Deviation 6.95

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24

Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.

The FACT-Lym measures 5 sub-scales which includes 42 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Lymphoma scale includes 15 items measured on 0-4 point scale. The total score for lymphoma sub-scale is sum of each 15 items (range: 0-60). Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

Outcome measures

Measure	Bendamustine Alone n=189 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=194 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Cycle 3 Day 1	0.98 units on a scale Standard Deviation 6.97	1.24 units on a scale Standard Deviation 5.71
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Follow-up Month 8	1.79 units on a scale Standard Deviation 6.01	2.52 units on a scale Standard Deviation 6.69
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Follow-up Month 10	1.90 units on a scale Standard Deviation 6.78	2.28 units on a scale Standard Deviation 6.82
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Follow-up Month 16	0.44 units on a scale Standard Deviation 7.79	3.27 units on a scale Standard Deviation 6.14
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Follow-up Month 18	1.18 units on a scale Standard Deviation 6.09	2.91 units on a scale Standard Deviation 6.79
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Follow-up Month 20	0.57 units on a scale Standard Deviation 7.43	2.83 units on a scale Standard Deviation 6.41
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Follow-up Month 22	1.89 units on a scale Standard Deviation 8.62	2.55 units on a scale Standard Deviation 6.58
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Extension Follow-up Month 6	0.92 units on a scale Standard Deviation 5.06	2.98 units on a scale Standard Deviation 7.22
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Extension Follow-up Month 18	1.80 units on a scale Standard Deviation 8.30	2.35 units on a scale Standard Deviation 5.72
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Extension Follow-up Month 24	4.89 units on a scale Standard Deviation 6.67	2.23 units on a scale Standard Deviation 6.85
CFB in FACT-Lym-Lymphoma Sub-scale Score Baseline	44.79 units on a scale Standard Deviation 9.66	45.61 units on a scale Standard Deviation 9.17
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Cycle 4 Day 1	-2.80 units on a scale Standard Deviation 5.76	9.50 units on a scale Standard Deviation 3.54
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Cycle 5 Day 1	0.75 units on a scale Standard Deviation 6.79	1.41 units on a scale Standard Deviation 6.21
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at End of Induction Treatment	1.64 units on a scale Standard Deviation 7.10	0.74 units on a scale Standard Deviation 7.89
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Follow-up Month 2	3.44 units on a scale Standard Deviation 6.78	2.45 units on a scale Standard Deviation 6.22
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Follow-up Month 4	2.77 units on a scale Standard Deviation 6.71	2.39 units on a scale Standard Deviation 6.54
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Follow-up Month 6	2.33 units on a scale Standard Deviation 6.44	3.00 units on a scale Standard Deviation 7.05
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Follow-up Month 12	2.12 units on a scale Standard Deviation 6.47	2.89 units on a scale Standard Deviation 6.42
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Follow-up Month 14	0.48 units on a scale Standard Deviation 6.64	2.58 units on a scale Standard Deviation 6.37
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Follow-up Month 24	0.66 units on a scale Standard Deviation 7.59	2.73 units on a scale Standard Deviation 6.48
CFB in FACT-Lym-Lymphoma Sub-scale Score CFB at Final Follow-up	1.62 units on a scale Standard Deviation 7.17	1.33 units on a scale Standard Deviation 7.38

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14

Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under "CFB at Follow-up Month 2" and "CFB at Follow-up Month 4" categories.

Outcome measures

Measure	Bendamustine Alone n=186 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=193 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase Baseline	0.77 units on a scale Standard Deviation 0.22	0.79 units on a scale Standard Deviation 0.20
CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase CFB at Cycle 3 Day 1	0.03 units on a scale Standard Deviation 0.21	0.00 units on a scale Standard Deviation 0.19
CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase CFB at End of Induction Treatment	0.01 units on a scale Standard Deviation 0.22	0.01 units on a scale Standard Deviation 0.20
CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase CFB at Cycle 4 Day 1	-0.10 units on a scale Standard Deviation 0.23	-0.07 units on a scale Standard Deviation 0.41
CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase CFB at Cycle 5 Day 1	0.01 units on a scale Standard Deviation 0.21	0.02 units on a scale Standard Deviation 0.20
CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase CFB at Follow-up Month 2	0.06 units on a scale Standard Deviation 0.24	0.04 units on a scale Standard Deviation 0.18
CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase CFB at Follow-up Month 4	—	-0.12 units on a scale Standard Deviation 0.00
CFB in Euro Quality of Life 5 Dimension (EuroQoL-5D/EQ-5D) - Health State Profile Utility Score During Induction Phase CFB at Follow-up Month 14	0.12 units on a scale Standard Deviation NA Standard deviation is non-evaluable due to low number of participants.	—

SECONDARY outcome

Timeframe: Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final follow-up (up to 2 years after end of induction) (End of induction = up to Month 6)

Population: ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single utility score. Health State Profile component assesses level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression; 1 indicates better health state (no problems); 3 indicates worst health state ("confined to bed"). Scoring formula developed by EuroQoL Group assigns a utility value for each domain in the profile. Score is transformed and results in a total score range -0.594 to 1.000; higher score indicates a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.

Outcome measures

Measure	Bendamustine Alone n=2 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=158 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase CFB at Follow-up Month 4	0.15 units on a scale Standard Deviation NA Standard deviation was not evaluable due to low number of participants.	0.03 units on a scale Standard Deviation 0.22
CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase CFB at Follow-up Month 6	0.15 units on a scale Standard Deviation NA Standard deviation was not evaluable due to low number of participants.	0.04 units on a scale Standard Deviation 0.19
CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase CFB at Follow-up Month 14	—	0.06 units on a scale Standard Deviation 0.19
CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase CFB at Follow-up Month 24	—	0.03 units on a scale Standard Deviation 0.22
CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase CFB at Follow-up Month 2	—	-0.15 units on a scale Standard Deviation 0.22
CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase CFB at Follow-up Month 8	0.15 units on a scale Standard Deviation NA Standard deviation is non-evaluable due to low number of participants.	0.04 units on a scale Standard Deviation 0.21
CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase CFB at Follow-up Month 10	0.15 units on a scale Standard Deviation NA Standard deviation was not evaluable due to low number of participants.	0.03 units on a scale Standard Deviation 0.20
CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase CFB at Follow-up Month 12	—	0.06 units on a scale Standard Deviation 0.18
CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase CFB at Follow-up Month 16	—	0.05 units on a scale Standard Deviation 0.19
CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase CFB at Follow-up Month 18	—	0.05 units on a scale Standard Deviation 0.18
CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase CFB at Follow-up Month 20	—	0.05 units on a scale Standard Deviation 0.20
CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase CFB at Follow-up Month 22	—	0.05 units on a scale Standard Deviation 0.24
CFB in EuroQol 5D (EQ-5D) - Health State Profile Utility Score During Maintenance Phase CFB at Final Follow-up	—	0.03 units on a scale Standard Deviation 0.25

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4 and 14

Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 millimeter (mm) (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). For 'Obinutuzumab + Bendamustine' arm, participants who had their follow-up Month 2 and 4 visits before start of maintenance treatment were reported in induction phase results under "CFB at Follow-up Month 2" and "CFB at Follow-up Month 4" categories.

Outcome measures

Measure	Bendamustine Alone n=183 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=188 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase CFB at Cycle 3 Day 1	0.91 units on a scale Standard Deviation 19.38	3.32 units on a scale Standard Deviation 15.99
CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase CFB at Cycle 5 Day 1	0.35 units on a scale Standard Deviation 20.79	5.17 units on a scale Standard Deviation 17.35
CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase CFB at End of Induction Treatment	5.71 units on a scale Standard Deviation 61.88	5.82 units on a scale Standard Deviation 22.20
CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase CFB at Follow-up Month 2	5.19 units on a scale Standard Deviation 19.12	6.85 units on a scale Standard Deviation 18.95
CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase CFB at Follow-up Month 4	—	0.00 units on a scale Standard Deviation 14.14
CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase CFB at Follow-up Month 14	10.00 units on a scale Standard Deviation NA Standard deviation is non-evaluable due to low number of participants.	—
CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase Baseline	69.48 units on a scale Standard Deviation 20.71	68.03 units on a scale Standard Deviation 21.69
CFB in EQ-5D Visual Analogue Scale (VAS) Score During Induction Phase CFB at Cycle 4 Day 1	-14.00 units on a scale Standard Deviation 33.29	-4.33 units on a scale Standard Deviation 42.15

SECONDARY outcome

Timeframe: Baseline, Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction) (end of induction = up to Month 6)

Population: ITT population (Obinutuzumab + Bendamustine arm only). Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point.

EQ-5D: participant rated questionnaire to assess health-related quality of life in terms of a single index value. The VAS component rates current health state on a scale from 0 mm (worst imaginable health state) to 100 mm (best imaginable health state); higher scores indicate a better health state. Data for this outcome was planned to be reported only for 'Obinutuzumab + Bendamustine' arm. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction). Follow-up months were during maintenance phase.

Outcome measures

Measure	Bendamustine Alone n=2 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=158 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
CFB in EQ-5D VAS Score During Maintenance Phase CFB at Follow-up Month 10	-15.00 units on a scale Standard Deviation NA SD data not applicable as only one participant was evaluable for this time point.	4.62 units on a scale Standard Deviation 16.28
CFB in EQ-5D VAS Score During Maintenance Phase CFB at Follow-up Month 2	—	-40.00 units on a scale Standard Deviation NA SD data not applicable as only one participant was evaluable for this time point.
CFB in EQ-5D VAS Score During Maintenance Phase CFB at Follow-up Month 8	5.00 units on a scale Standard Deviation NA SD data not applicable as only one participant was evaluable for this time point.	4.79 units on a scale Standard Deviation 17.18
CFB in EQ-5D VAS Score During Maintenance Phase CFB at Follow-up Month 12	—	5.73 units on a scale Standard Deviation 16.04
CFB in EQ-5D VAS Score During Maintenance Phase CFB at Follow-up Month 14	—	5.45 units on a scale Standard Deviation 17.36
CFB in EQ-5D VAS Score During Maintenance Phase CFB at Follow-up Month 16	—	6.66 units on a scale Standard Deviation 17.44
CFB in EQ-5D VAS Score During Maintenance Phase CFB at Follow-up Month 18	—	6.13 units on a scale Standard Deviation 19.44
CFB in EQ-5D VAS Score During Maintenance Phase CFB at Follow-up Month 20	—	7.56 units on a scale Standard Deviation 15.43
CFB in EQ-5D VAS Score During Maintenance Phase CFB at Follow-up Month 22	—	6.97 units on a scale Standard Deviation 15.55
CFB in EQ-5D VAS Score During Maintenance Phase CFB at Follow-up Month 24	—	8.28 units on a scale Standard Deviation 16.23
CFB in EQ-5D VAS Score During Maintenance Phase CFB at Final Follow-up	—	4.47 units on a scale Standard Deviation 14.91
CFB in EQ-5D VAS Score During Maintenance Phase CFB at Follow-up Month 4	5.00 units on a scale Standard Deviation NA SD data not applicable as only one participant was evaluable for this time point.	5.59 units on a scale Standard Deviation 19.61
CFB in EQ-5D VAS Score During Maintenance Phase CFB at Follow-up Month 6	5.00 units on a scale Standard Deviation NA SD data not applicable as only one participant was evaluable for this time point.	6.04 units on a scale Standard Deviation 19.00

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24

Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome and "n" signified those participants who were evaluable for a specified time point.

The FACT-G is the sum of 4 sub-scales (physical, social, emotional and functional well-being) of FACT-Lym which includes total 27 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-108. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

Outcome measures

Measure	Bendamustine Alone n=185 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=186 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score Baseline	79.86 Units on a scale Standard Deviation 16.25	80.78 Units on a scale Standard Deviation 16.27
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Cycle 3 Day 1	-1.87 Units on a scale Standard Deviation 12.28	0.11 Units on a scale Standard Deviation 10.30
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Cycle 4 Day 1	-9.37 Units on a scale Standard Deviation 9.89	0.52 Units on a scale Standard Deviation 4.98
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Cycle 5 Day 1	-2.44 Units on a scale Standard Deviation 12.01	0.06 Units on a scale Standard Deviation 11.13
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Follow-up Month 2	1.53 Units on a scale Standard Deviation 13.42	1.22 Units on a scale Standard Deviation 12.01
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Follow-up Month 4	2.55 Units on a scale Standard Deviation 11.47	3.06 Units on a scale Standard Deviation 13.00
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Follow-up Month 6	2.54 Units on a scale Standard Deviation 10.68	3.24 Units on a scale Standard Deviation 11.40
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Follow-up Month 10	2.29 Units on a scale Standard Deviation 11.39	3.46 Units on a scale Standard Deviation 11.83
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Follow-up Month 12	0.68 Units on a scale Standard Deviation 13.16	2.82 Units on a scale Standard Deviation 14.29
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Follow-up Month 20	-1.21 Units on a scale Standard Deviation 12.25	3.05 Units on a scale Standard Deviation 14.29
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Follow-up Month 24	-2.39 Units on a scale Standard Deviation 9.32	2.28 Units on a scale Standard Deviation 13.83
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Extension Follow Up Month 24	4.48 Units on a scale Standard Deviation 11.10	4.47 Units on a scale Standard Deviation 15.22
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at End of Induction Treatment	-1.84 Units on a scale Standard Deviation 13.83	-0.92 Units on a scale Standard Deviation 11.77
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Follow-up Month 8	-0.53 Units on a scale Standard Deviation 10.15	2.49 Units on a scale Standard Deviation 11.45
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Follow-up Month 14	2.48 Units on a scale Standard Deviation 9.42	2.94 Units on a scale Standard Deviation 11.97
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Follow-up Month 16	1.54 Units on a scale Standard Deviation 10.61	4.09 Units on a scale Standard Deviation 12.87
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Follow-up Month 18	1.16 Units on a scale Standard Deviation 11.57	4.06 Units on a scale Standard Deviation 13.36
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Follow-up Month 22	0.64 Units on a scale Standard Deviation 14.27	1.80 Units on a scale Standard Deviation 12.43
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Final Follow-up	0.50 Units on a scale Standard Deviation 11.25	0.78 Units on a scale Standard Deviation 14.94
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Extension Follow Up Month 6	0.48 Units on a scale Standard Deviation 8.71	1.74 Units on a scale Standard Deviation 14.23
CFB in Functional Assessment of Cancer Therapy - Generic (FACT-G) Score CFB at Extension Follow Up Month 18	2.29 Units on a scale Standard Deviation 8.40	4.56 Units on a scale Standard Deviation 15.02

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24

Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.

TOI is the sum of 3 sub-scales (physical well-being, functional well-being, and Lymphoma sub-scale) of FACT-Lym which includes total 29 items; responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

Outcome measures

Measure	Bendamustine Alone n=190 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=196 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
CFB in FACT-Lym Trial Outcome Index (TOI) Baseline	84.66 Units on a scale Standard Deviation 19.36	84.76 Units on a scale Standard Deviation 18.97
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Cycle 4 Day 1	-10.40 Units on a scale Standard Deviation 10.38	26.44 Units on a scale Standard Deviation 19.51
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Cycle 5 Day 1	-1.38 Units on a scale Standard Deviation 15.38	2.37 Units on a scale Standard Deviation 14.15
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Follow-up Month 2	3.75 Units on a scale Standard Deviation 15.36	4.60 Units on a scale Standard Deviation 14.85
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Follow-up Month 10	3.52 Units on a scale Standard Deviation 13.16	4.94 Units on a scale Standard Deviation 15.96
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Follow-up Month 12	2.05 Units on a scale Standard Deviation 15.14	6.13 Units on a scale Standard Deviation 15.72
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Follow-up Month 14	2.25 Units on a scale Standard Deviation 11.92	5.13 Units on a scale Standard Deviation 14.30
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Follow-up Month 16	0.75 Units on a scale Standard Deviation 14.15	6.78 Units on a scale Standard Deviation 15.11
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Follow-up Month 20	-0.64 Units on a scale Standard Deviation 15.21	6.36 Units on a scale Standard Deviation 14.99
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Follow-up Month 22	2.26 Units on a scale Standard Deviation 14.54	5.30 Units on a scale Standard Deviation 17.88
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Final Follow-up	0.84 Units on a scale Standard Deviation 14.80	3.84 Units on a scale Standard Deviation 16.22
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Extension Follow Up Month 24	10.04 Units on a scale Standard Deviation 13.35	7.07 Units on a scale Standard Deviation 17.59
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Cycle 3 Day 1	-1.94 Units on a scale Standard Deviation 17.96	1.81 Units on a scale Standard Deviation 13.88
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at End of Induction Treatment	-0.52 Units on a scale Standard Deviation 17.23	0.40 Units on a scale Standard Deviation 16.45
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Follow-up Month 4	3.81 Units on a scale Standard Deviation 13.39	5.18 Units on a scale Standard Deviation 17.06
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Follow-up Month 6	3.26 Units on a scale Standard Deviation 12.19	6.07 Units on a scale Standard Deviation 13.72
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Follow-up Month 8	1.36 Units on a scale Standard Deviation 12.39	5.36 Units on a scale Standard Deviation 14.21
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Follow-up Month 18	1.36 Units on a scale Standard Deviation 11.30	7.26 Units on a scale Standard Deviation 14.62
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Follow-up Month 24	-0.14 Units on a scale Standard Deviation 13.44	5.30 Units on a scale Standard Deviation 17.88
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Extension Follow Up Month 6	2.30 Units on a scale Standard Deviation 10.77	5.53 Units on a scale Standard Deviation 18.44
CFB in FACT-Lym Trial Outcome Index (TOI) CFB at Extension Follow Up Month 18	4.02 Units on a scale Standard Deviation 14.01	7.31 Units on a scale Standard Deviation 15.69

SECONDARY outcome

Timeframe: Baseline, Day 1 of Cycles 3, 4, 5, End of induction treatment (up to Month 6); Follow-up Months 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, Final Follow-up (up to 2 years after end of induction); Extension follow-up Months 6, 18 and 24

Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.

FACT-Lym total score is the sum of physical well-being score (7 items), social/family well-being (7 items), emotional well-being (6 items), functional well-being (7 items), and Lymphoma sub-scale (15 items); responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-168. Higher scores indicate a better PRO/QoL. In timeframe, follow-up months represents months after end of induction (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

Outcome measures

Measure	Bendamustine Alone n=186 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=187 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
CFB in FACT-Lym Total Score Baseline	124.56 Units on a scale Standard Deviation 24.17	126.22 Units on a scale Standard Deviation 23.98
CFB in FACT-Lym Total Score CFB at Cycle 3 Day 1	-0.74 Units on a scale Standard Deviation 17.91	1.33 Units on a scale Standard Deviation 13.89
CFB in FACT-Lym Total Score CFB at Cycle 4 Day 1	-12.16 Units on a scale Standard Deviation 14.80	22.53 Units on a scale Standard Deviation 16.23
CFB in FACT-Lym Total Score CFB at Cycle 5 Day 1	-1.68 Units on a scale Standard Deviation 16.61	1.71 Units on a scale Standard Deviation 15.23
CFB in FACT-Lym Total Score CFB at End of Induction Treatment	0.02 Units on a scale Standard Deviation 18.55	0.35 Units on a scale Standard Deviation 18.29
CFB in FACT-Lym Total Score CFB at Follow-up Month 2	5.10 Units on a scale Standard Deviation 17.73	3.54 Units on a scale Standard Deviation 15.45
CFB in FACT-Lym Total Score CFB at Follow-up Month 4	5.40 Units on a scale Standard Deviation 16.29	5.50 Units on a scale Standard Deviation 17.76
CFB in FACT-Lym Total Score CFB at Follow-up Month 6	5.03 Units on a scale Standard Deviation 15.01	6.57 Units on a scale Standard Deviation 15.96
CFB in FACT-Lym Total Score CFB at Follow-up Month 8	1.48 Units on a scale Standard Deviation 14.27	5.18 Units on a scale Standard Deviation 15.61
CFB in FACT-Lym Total Score CFB at Follow-up Month 10	4.58 Units on a scale Standard Deviation 16.39	5.70 Units on a scale Standard Deviation 16.89
CFB in FACT-Lym Total Score CFB at Follow-up Month 12	2.97 Units on a scale Standard Deviation 17.84	5.88 Units on a scale Standard Deviation 18.93
CFB in FACT-Lym Total Score CFB at Follow-up Month 14	3.18 Units on a scale Standard Deviation 13.85	5.92 Units on a scale Standard Deviation 17.06
CFB in FACT-Lym Total Score CFB at Follow-up Month 16	2.25 Units on a scale Standard Deviation 14.98	7.59 Units on a scale Standard Deviation 16.97
CFB in FACT-Lym Total Score CFB at Follow-up Month 18	2.16 Units on a scale Standard Deviation 15.38	6.99 Units on a scale Standard Deviation 18.27
CFB in FACT-Lym Total Score CFB at Follow-up Month 24	-2.13 Units on a scale Standard Deviation 15.74	5.28 Units on a scale Standard Deviation 18.75
CFB in FACT-Lym Total Score CFB at Extension Follow Up Month 18	4.92 Units on a scale Standard Deviation 14.73	6.88 Units on a scale Standard Deviation 19.24
CFB in FACT-Lym Total Score CFB at Extension Follow Up Month 24	9.69 Units on a scale Standard Deviation 15.88	6.13 Units on a scale Standard Deviation 20.32
CFB in FACT-Lym Total Score CFB at Follow-up Month 20	-0.89 Units on a scale Standard Deviation 16.34	5.66 Units on a scale Standard Deviation 18.90
CFB in FACT-Lym Total Score CFB at Follow-up Month 22	2.15 Units on a scale Standard Deviation 19.03	4.59 Units on a scale Standard Deviation 17.98
CFB in FACT-Lym Total Score CFB at Final follow-up	2.15 Units on a scale Standard Deviation 16.60	2.55 Units on a scale Standard Deviation 20.11
CFB in FACT-Lym Total Score CFB at Extension Follow Up Month 6	1.22 Units on a scale Standard Deviation 11.67	5.14 Units on a scale Standard Deviation 20.30

SECONDARY outcome

Timeframe: Baseline up to approximately 8.5 years

Population: ITT population.

The median time, in month, from date of randomization until a clinically meaningful decline from baseline in TOI or death, whichever occurred first. TOI: sum of physical well-being score,functional well-being score, and Lymphoma sub-scale of FACT-Lym; total 29 items, responses to each item range from 0, "Not at all" to 4, "Very much". Total score ranges from 0-116. Higher scores indicate a better PRO/QoL. A clinically meaningful decline in TOI score was defined as at least a 6 point decline from baseline. Time to deterioration was estimated using Kaplan-Meier method and 95% CI for median was computed using the method of Brookmeyer and Crowley. In timeframe, follow-up months represents months after end of induction (EOI) (e.g. Follow-up Month 2 is 2 months after end of induction) and extension follow-up months represents months after end of 2 years normal follow-up (e.g. extension follow-up Month 6 is 6 months after end of normal 2 year follow-up).

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Time to Deterioration of FACT-Lym TOI	5.6 Months Interval 3.9 to 7.0	8.0 Months Interval 5.9 to 14.7

SECONDARY outcome

Timeframe: Baseline, Cycle 5 Day 1 (C5D1) (Cycle length = 28 days), Follow-up Months 6 (FUM6), 12 (FUM12), 18 (FUM18), 24 (FUM24), Extension Follow Up Month 6 (Extension FUM6)

Population: ITT population. Here, number of participants analyzed signified those participants who were evaluable for this outcome.

FACT-Lym: 42-items in 5 subscales. Responses to each item range from 0 (Not at all) to 4 (Very much). FACT-Lym Lymphoma subscale includes 15 items (total score range = 0-60). FACT-Lym TOI is sum of 3 subscales (physical well-being, functional well-being, lymphoma subscale) and includes 29 items (total score range = 0-116). FACT-Lym total score is sum of 42 items (total score ranges from 0-168). For all above, higher scores indicate a better PRO/QoL. DI from baseline: at least 3 point increase from baseline in FACT-Lym Lymphoma subscale; at least 6 point increase from baseline in FACT Lym TOI; at least 7 point increase from baseline in FACT Lym total scores. In timeframe, follow-up months represents months after EOI (e.g. Follow-up Month 2 is 2 months after EOI; EOI = up to Month 6).

Outcome measures

Measure	Bendamustine Alone n=209 Participants Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 Participants Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores FUM18 (>=3 pt increase)	35.6 Percentage of participants	53.0 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores FUM12 (>=6 pt increase)	26.2 Percentage of participants	47.0 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores C5D1 (>=3 pt increase)	30.3 Percentage of participants	41.7 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores FUM6 (>=3 pt increase)	37.9 Percentage of participants	47.1 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores FUM12 (>=3 pt increase)	36.7 Percentage of participants	46.5 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores FUM24 (>=3 pt increase)	35.3 Percentage of participants	50 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores Ext FUM6 (>=3 pt increase)	36.0 Percentage of participants	57.8 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores C5D1 (>=6 pt increase)	23.1 Percentage of participants	34.4 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores FUM6 (>=6 pt increase)	29.5 Percentage of participants	43.7 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores FUM18 (>=6 pt increase)	28.9 Percentage of participants	51.8 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores FUM24 (>=6 pt increase)	26.5 Percentage of participants	48.0 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores Ext FUM6 (>=6 pt increase)	44 Percentage of participants	56.9 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores C5D1 (>=7 pt increase)	24.4 Percentage of participants	28.0 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores FUM6 (>=7 pt increase)	34.1 Percentage of participants	40.3 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores FUM12 (>=7 pt increase)	31.1 Percentage of participants	45.0 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores FUM18 (>=7 pt increase)	31.1 Percentage of participants	43.4 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores FUM24 (>=7 pt increase)	20.6 Percentage of participants	42.7 Percentage of participants
Percentage of Participants With Definitive Improvement (DI) From Baseline in FACT-Lym Instrument Scores Ext FUM6 (>=7 pt increase)	32 Percentage of participants	47.7 Percentage of participants

Adverse Events

Bendamustine Alone

Serious events: 76 serious events

Other events: 194 other events

Deaths: 0 deaths

Obinutuzumab + Bendamustine

Serious events: 91 serious events

Other events: 200 other events

Deaths: 0 deaths

Serious adverse events

Measure	Bendamustine Alone n=203 participants at risk Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 participants at risk Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Blood and lymphatic system disorders AGRANULOCYTOSIS	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Blood and lymphatic system disorders ANAEMIA	1.5% 3/203 • Number of events 3 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	1.5% 3/204 • Number of events 3 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	3.0% 6/203 • Number of events 6 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	5.4% 11/204 • Number of events 17 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Blood and lymphatic system disorders LEUKOPENIA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Blood and lymphatic system disorders NEUTROPENIA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	2.9% 6/204 • Number of events 6 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	2.5% 5/204 • Number of events 5 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Cardiac disorders ATRIAL FIBRILLATION	0.49% 1/203 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Cardiac disorders ATRIAL FLUTTER	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Cardiac disorders CARDIAC FAILURE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 3 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Cardiac disorders MYOCARDIAL INFARCTION	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Cardiac disorders PAROXYSMAL ARRHYTHMIA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Congenital, familial and genetic disorders HYDROCELE	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Eye disorders NECROTISING RETINITIS	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders ANAL FISSURE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders COLITIS	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders DIARRHOEA	1.5% 3/203 • Number of events 3 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders FOOD POISONING	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders GASTROINTESTINAL HAEMORRHAGE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders HAEMATOCHEZIA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders INTESTINAL PERFORATION	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders LARGE INTESTINAL OBSTRUCTION	0.49% 1/203 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders MELAENA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders NAUSEA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders PANCREATITIS	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders RECTAL HAEMORRHAGE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders UPPER GASTROINTESTINAL HAEMORRHAGE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders VOMITING	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders CATHETER SITE PAIN	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders CHEST PAIN	0.99% 2/203 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders FATIGUE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	1.5% 3/204 • Number of events 4 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders HYPERTHERMIA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders INFLUENZA LIKE ILLNESS	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders MALAISE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders PYREXIA	1.5% 3/203 • Number of events 3 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	2.9% 6/204 • Number of events 7 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Hepatobiliary disorders CHOLECYSTITIS	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Immune system disorders GRAFT VERSUS HOST DISEASE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations ATYPICAL PNEUMONIA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations BACTERAEMIA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations BRONCHITIS	1.5% 3/203 • Number of events 3 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations CAMPYLOBACTER INFECTION	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations COXSACKIE MYOCARDITIS	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations DEVICE RELATED SEPSIS	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations ENCEPHALITIS VIRAL	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations ENDOCARDITIS	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations ERYSIPELAS	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations ESCHERICHIA SEPSIS	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations FUNGAL SEPSIS	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations GASTROENTERITIS	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations GASTROENTERITIS NOROVIRUS	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations HEPATITIS B REACTIVATION	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations HERPES ZOSTER	1.5% 3/203 • Number of events 3 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations INFECTION	0.99% 2/203 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	0.49% 1/203 • Number of events 5 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	1.5% 3/204 • Number of events 3 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations LUNG INFECTION	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations LUNG INFECTION PSEUDOMONAL	0.49% 1/203 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations NEUTROPENIC SEPSIS	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations PNEUMOCYSTIS JIROVECII PNEUMONIA	0.99% 2/203 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations PNEUMONIA	5.9% 12/203 • Number of events 12 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	3.4% 7/204 • Number of events 7 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations PNEUMONIA CYTOMEGALOVIRAL	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations PSEUDOMONAL SEPSIS	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations PSEUDOMONAS BRONCHITIS	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations RESPIRATORY SYNCYTIAL VIRUS INFECTION	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations RESPIRATORY TRACT INFECTION	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations SEPSIS	3.4% 7/203 • Number of events 7 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	2.9% 6/204 • Number of events 6 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations SEPTIC SHOCK	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations SINUSITIS	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations STAPHYLOCOCCAL SEPSIS	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations TOOTH INFECTION	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations URINARY TRACT INFECTION	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	1.5% 3/204 • Number of events 3 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations UROSEPSIS	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations VASCULAR DEVICE INFECTION	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Injury, poisoning and procedural complications FEMUR FRACTURE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Injury, poisoning and procedural complications HEAD INJURY	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Injury, poisoning and procedural complications HIP FRACTURE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	1.5% 3/203 • Number of events 3 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	3.4% 7/204 • Number of events 7 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Injury, poisoning and procedural complications JAW FRACTURE	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Injury, poisoning and procedural complications POST PROCEDURAL BILE LEAK	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Injury, poisoning and procedural complications SEROMA	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Injury, poisoning and procedural complications STAB WOUND	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Injury, poisoning and procedural complications VASCULAR PSEUDOANEURYSM	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Injury, poisoning and procedural complications WRIST FRACTURE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Investigations BLOOD CREATININE INCREASED	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Investigations BORRELIA TEST	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Metabolism and nutrition disorders DEHYDRATION	0.99% 2/203 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Metabolism and nutrition disorders HYPOKALAEMIA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Metabolism and nutrition disorders TUMOUR LYSIS SYNDROME	0.99% 2/203 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Musculoskeletal and connective tissue disorders MUSCLE HAEMORRHAGE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ACUTE MYELOID LEUKAEMIA	0.99% 2/203 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOCARCINOMA GASTRIC	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BASAL CELL CARCINOMA	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BRONCHIAL NEOPLASM	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHOLANGIOCARCINOMA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) COLORECTAL CANCER	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INTESTINAL ADENOCARCINOMA	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LEIOMYOSARCOMA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LEUKAEMIA	0.99% 2/203 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG NEOPLASM MALIGNANT	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MELANOMA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MYELODYSPLASTIC SYNDROME	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	1.5% 3/204 • Number of events 3 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) POLYCYTHAEMIA VERA	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RENAL CANCER	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	1.5% 3/203 • Number of events 3 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) T-CELL LYMPHOMA	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) THYROID NEOPLASM	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Nervous system disorders AMYOTROPHIC LATERAL SCLEROSIS	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Nervous system disorders CENTRAL NERVOUS SYSTEM LESION	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Nervous system disorders HEADACHE	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Nervous system disorders ISCHAEMIC STROKE	0.99% 2/203 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Nervous system disorders POST HERPETIC NEURALGIA	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Nervous system disorders PRESYNCOPE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Nervous system disorders SYNCOPE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Psychiatric disorders ANXIETY	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Psychiatric disorders MANIA	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Renal and urinary disorders DYSURIA	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Renal and urinary disorders END STAGE RENAL DISEASE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Renal and urinary disorders HAEMATURIA	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Renal and urinary disorders POLLAKIURIA	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Renal and urinary disorders URETERIC OBSTRUCTION	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Renal and urinary disorders URINARY INCONTINENCE	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Respiratory, thoracic and mediastinal disorders BRONCHOSPASM	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Respiratory, thoracic and mediastinal disorders CHYLOTHORAX	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Respiratory, thoracic and mediastinal disorders EMPHYSEMA	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Respiratory, thoracic and mediastinal disorders PNEUMONIA ASPIRATION	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Respiratory, thoracic and mediastinal disorders PNEUMOTHORAX	0.00% 0/203 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	1.5% 3/203 • Number of events 3 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.49% 1/204 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Skin and subcutaneous tissue disorders PARANEOPLASTIC PEMPHIGUS	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Social circumstances SOCIAL PROBLEM	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Vascular disorders CIRCULATORY COLLAPSE	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Vascular disorders DEEP VEIN THROMBOSIS	0.49% 1/203 • Number of events 1 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.00% 0/204 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Vascular disorders HYPOTENSION	0.99% 2/203 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	0.98% 2/204 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.

Other adverse events

Measure	Bendamustine Alone n=203 participants at risk Participants received Bendamustine 120 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle for up to six cycles.	Obinutuzumab + Bendamustine n=204 participants at risk Induction phase: Participants received Bendamustine 90 mg/m\^2 IV on Days 2 and 3 of Cycle 1 and on Days 1 and 2 of Cycles 2-6 (28-day cycles) for the first 10 participants and on Days 1 and 2 of each 28-day cycle for Cycles 1-6 for remaining participants. Participants also received obinutuzumab 1000 mg IV infusion on Days 1, 8, and 15 of Cycle 1; Day 1 of Cycles 2-6. Maintenance phase: Participants with CR, PR or SD then received obinutuzumab 1000 mg IV infusion every 2 months until disease progression or for up to 2 years (whichever occurred first).
Blood and lymphatic system disorders ANAEMIA	16.7% 34/203 • Number of events 41 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	11.3% 23/204 • Number of events 36 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Blood and lymphatic system disorders NEUTROPENIA	29.1% 59/203 • Number of events 103 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	36.3% 74/204 • Number of events 150 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Blood and lymphatic system disorders THROMBOCYTOPENIA	24.6% 50/203 • Number of events 101 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	12.7% 26/204 • Number of events 54 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders ABDOMINAL DISTENSION	5.4% 11/203 • Number of events 12 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	2.9% 6/204 • Number of events 6 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders ABDOMINAL PAIN	9.9% 20/203 • Number of events 23 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	7.8% 16/204 • Number of events 18 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	7.4% 15/203 • Number of events 19 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	5.4% 11/204 • Number of events 12 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders CONSTIPATION	19.7% 40/203 • Number of events 55 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	20.6% 42/204 • Number of events 56 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders DIARRHOEA	30.0% 61/203 • Number of events 83 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	27.9% 57/204 • Number of events 81 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders DRY MOUTH	5.9% 12/203 • Number of events 15 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	3.9% 8/204 • Number of events 8 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders DYSPEPSIA	4.4% 9/203 • Number of events 11 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	6.4% 13/204 • Number of events 16 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders NAUSEA	60.6% 123/203 • Number of events 227 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	52.5% 107/204 • Number of events 210 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Gastrointestinal disorders VOMITING	26.6% 54/203 • Number of events 87 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	21.6% 44/204 • Number of events 67 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders ASTHENIA	12.3% 25/203 • Number of events 35 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	15.2% 31/204 • Number of events 44 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders CHEST PAIN	2.0% 4/203 • Number of events 4 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	5.4% 11/204 • Number of events 11 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders CHILLS	10.3% 21/203 • Number of events 24 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	13.7% 28/204 • Number of events 30 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders FATIGUE	33.0% 67/203 • Number of events 114 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	39.7% 81/204 • Number of events 151 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders INFLUENZA LIKE ILLNESS	4.4% 9/203 • Number of events 10 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	5.4% 11/204 • Number of events 12 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders MUCOSAL INFLAMMATION	3.9% 8/203 • Number of events 11 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	5.4% 11/204 • Number of events 12 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders OEDEMA PERIPHERAL	6.9% 14/203 • Number of events 17 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	7.4% 15/204 • Number of events 16 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
General disorders PYREXIA	17.7% 36/203 • Number of events 44 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	26.5% 54/204 • Number of events 80 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations BRONCHITIS	8.9% 18/203 • Number of events 23 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	11.8% 24/204 • Number of events 36 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations HERPES ZOSTER	6.9% 14/203 • Number of events 16 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	4.9% 10/204 • Number of events 10 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations NASOPHARYNGITIS	3.9% 8/203 • Number of events 10 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	10.8% 22/204 • Number of events 27 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations RHINITIS	3.9% 8/203 • Number of events 9 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	5.9% 12/204 • Number of events 13 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations SINUSITIS	5.4% 11/203 • Number of events 14 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	11.8% 24/204 • Number of events 35 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	8.4% 17/203 • Number of events 21 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	12.7% 26/204 • Number of events 34 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Infections and infestations URINARY TRACT INFECTION	5.9% 12/203 • Number of events 14 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	11.3% 23/204 • Number of events 36 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	56.7% 115/203 • Number of events 242 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	61.3% 125/204 • Number of events 283 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Investigations WEIGHT DECREASED	8.9% 18/203 • Number of events 18 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	5.4% 11/204 • Number of events 11 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Metabolism and nutrition disorders DECREASED APPETITE	18.2% 37/203 • Number of events 49 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	18.1% 37/204 • Number of events 40 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Metabolism and nutrition disorders HYPOKALAEMIA	7.4% 15/203 • Number of events 21 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	7.4% 15/204 • Number of events 22 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Musculoskeletal and connective tissue disorders ARTHRALGIA	5.4% 11/203 • Number of events 12 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	11.8% 24/204 • Number of events 31 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Musculoskeletal and connective tissue disorders BACK PAIN	8.9% 18/203 • Number of events 22 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	8.3% 17/204 • Number of events 19 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Musculoskeletal and connective tissue disorders MYALGIA	7.4% 15/203 • Number of events 17 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	6.4% 13/204 • Number of events 14 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	4.9% 10/203 • Number of events 13 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	10.8% 22/204 • Number of events 27 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Nervous system disorders DIZZINESS	8.4% 17/203 • Number of events 23 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	6.9% 14/204 • Number of events 22 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Nervous system disorders DYSGEUSIA	7.9% 16/203 • Number of events 20 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	7.4% 15/204 • Number of events 20 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Nervous system disorders HEADACHE	15.8% 32/203 • Number of events 37 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	13.2% 27/204 • Number of events 36 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Psychiatric disorders INSOMNIA	10.3% 21/203 • Number of events 26 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	10.3% 21/204 • Number of events 24 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Respiratory, thoracic and mediastinal disorders COUGH	19.7% 40/203 • Number of events 46 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	31.4% 64/204 • Number of events 85 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	11.3% 23/203 • Number of events 28 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	12.7% 26/204 • Number of events 27 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Respiratory, thoracic and mediastinal disorders NASAL CONGESTION	2.5% 5/203 • Number of events 6 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	8.3% 17/204 • Number of events 18 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	3.4% 7/203 • Number of events 7 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	5.9% 12/204 • Number of events 15 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	1.5% 3/203 • Number of events 3 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	5.4% 11/204 • Number of events 11 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Skin and subcutaneous tissue disorders PRURITUS	5.9% 12/203 • Number of events 13 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	14.2% 29/204 • Number of events 38 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Skin and subcutaneous tissue disorders RASH	11.8% 24/203 • Number of events 27 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	13.7% 28/204 • Number of events 35 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Vascular disorders HYPOTENSION	0.49% 1/203 • Number of events 2 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	11.3% 23/204 • Number of events 26 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.
Vascular disorders PHLEBITIS	6.4% 13/203 • Number of events 14 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.	5.4% 11/204 • Number of events 11 • Baseline up to 8.5 years Safety population included all participants who received any amount of obinutuzumab or bendamustine therapy.

Additional Information

Medical Communications

Genentech

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Results disclosure agreements

• Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
• Publication restrictions are in place

Restriction type: OTHER