Trial Outcomes & Findings for A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) (NCT NCT02005471)

NCT ID: NCT02005471

Last Updated: 2023-10-17

Results Overview

Assessment of response was performed by the investigator according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (greater than \[\>\] 1.5 centimeters \[cm\]); unequivocal progression of non-target lesion; an increase of greater than or equal to (\>/=) 50 percent (%) compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count \>/=5000 per microliter (mcL), or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of \>/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by \>2 grams per deciliter (g/dL) or to less than \[\<\] 10 g/dL. Percentages are rounded off.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 389 participants
• Primary outcome timeframe: Baseline up to PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)
• Results posted on: 2023-10-17

Participant Flow

A total 389 participants took part in the study across 109 investigative sites in 20 countries i.e., Korea, Taiwan, Australia, New Zealand, Czech Republic, Hungary, Poland, Russia, Canada, United States of America, Austria, Belgium, Germany, Denmark, Spain, France, United Kingdom, Italy, Netherlands and Sweden from 17 March 2014 to 03 August 2022. The trial consisted of a main study and an optional Retreatment/Crossover (R/C) sub study.

Of the 389 participants enrolled 7 participants in the bendamustine + rituximab (BR) arm did not receive a valid dose of study treatment.

Participant milestones

Measure	Bendamustine + Rituximab Main Study Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to progressive disease (PD) or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Bendamustine + Rituximab Crossover Substudy Participants who entered the crossover substudy had a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, participants received 6 cycles of rituximab, 375 mg/m\^2, as IV infusion on the Day 1 of each 28-day cycle. Participants who did not progress following the completion of the 6 cycles continued to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 crossover Day 1 of the substudy.	Venetoclax + Rituximab Re-Treatment Substudy Participants who entered the re-treatment substudy had a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, participants received 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants who did not progress following the completion of the 6 cycles continued to receive venetoclax monotherapy until disease progression or for a maximum of 2 year from Cycle 1 re-treatment Day 1 of the substudy.
Main Study STARTED	195	194	0	0
Main Study Safety Evaluable (SE) Population	188	194	0	0
Main Study COMPLETED	71	118	0	0
Main Study NOT COMPLETED	124	76	0	0
Re-Treatment/Crossover (R/C) Substudy STARTED	0	0	9	25
Re-Treatment/Crossover (R/C) Substudy COMPLETED	0	0	7	15
Re-Treatment/Crossover (R/C) Substudy NOT COMPLETED	0	0	2	10

Reasons for withdrawal

Measure	Bendamustine + Rituximab Main Study Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to progressive disease (PD) or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Bendamustine + Rituximab Crossover Substudy Participants who entered the crossover substudy had a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, participants received 6 cycles of rituximab, 375 mg/m\^2, as IV infusion on the Day 1 of each 28-day cycle. Participants who did not progress following the completion of the 6 cycles continued to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 crossover Day 1 of the substudy.	Venetoclax + Rituximab Re-Treatment Substudy Participants who entered the re-treatment substudy had a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, participants received 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants who did not progress following the completion of the 6 cycles continued to receive venetoclax monotherapy until disease progression or for a maximum of 2 year from Cycle 1 re-treatment Day 1 of the substudy.
Main Study Adverse Event	0	1	0	0
Main Study Death	83	52	0	0
Main Study Lost to Follow-up	4	5	0	0
Main Study Physician Decision	3	1	0	0
Main Study Withdrawal by Subject	26	11	0	0
Main Study Reason not Specified	0	6	0	0
Main Study Randomized but not Dosed	8	0	0	0
Re-Treatment/Crossover (R/C) Substudy Withdrawal by Subject	0	0	0	1
Re-Treatment/Crossover (R/C) Substudy Lost to Follow-up	0	0	1	1
Re-Treatment/Crossover (R/C) Substudy Death	0	0	1	8

Baseline Characteristics

A Study to Evaluate the Benefit of Venetoclax Plus Rituximab Compared With Bendamustine Plus Rituximab in Participants With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)

Baseline characteristics by cohort

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Total n=389 Participants Total of all reporting groups
Age, Continuous	64.4 years STANDARD_DEVIATION 9.6 • n=5 Participants	63.9 years STANDARD_DEVIATION 10.5 • n=7 Participants	64.1 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	44 Participants n=5 Participants	58 Participants n=7 Participants	102 Participants n=5 Participants
Sex: Female, Male Male	151 Participants n=5 Participants	136 Participants n=7 Participants	287 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	186 Participants n=5 Participants	186 Participants n=7 Participants	372 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	178 Participants n=5 Participants	181 Participants n=7 Participants	359 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants	7 Participants n=7 Participants	18 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

Assessment of response was performed by the investigator according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (greater than [>] 1.5 centimeters [cm]); unequivocal progression of non-target lesion; an increase of greater than or equal to (>/=) 50 percent (%) compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count >/=5000 per microliter (mcL), or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of >/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by >2 grams per deciliter (g/dL) or to less than [<] 10 g/dL. Percentages are rounded off.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Percentage of Participants With PD as Assessed by the Investigator Using Standard International Workshop on Chronic Lymphocytic Leukemia (iwCLL) Guidelines or Death	88.7 percentage of participants	70.1 percentage of participants

PRIMARY outcome

Timeframe: Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the investigator using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; increase of >/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count >/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of >/=50% in platelet or neutrophil count, or hemoglobin level by >2 g/dL or to <10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% confidence interval (CI) was computed using method of Brookmeyer and Crowley.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Progression-Free Survival (PFS) as Assessed by the Investigator Using Standard iwCLL Guidelines	17.0 months Interval 15.5 to 21.7	54.7 months Interval 52.3 to 59.9

SECONDARY outcome

Timeframe: Baseline up to PD or death, whichever occurred first (up to approximately 3 years)

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

Assessment of response was performed by the IRC according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; an increase of >/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count >/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of >/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by >2 g/dL or to <10 g/dL. No new IRC data was generated post the primary analysis.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Percentage of Participants With PD or Death as Assessed by the Independent Review Committee (IRC) Using Standard iwCLL Guidelines	54.4 percentage of participants	18.0 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to PD or death, whichever occurred first (up to approximately 3 years)

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the IRC using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; increase of >/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count >/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of >/=50% in platelet or neutrophil count, or hemoglobin level by >2 g/dL or to <10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. No new IRC data was generated post the primary analysis.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
PFS as Assessed by the IRC Using Standard iwCLL Guidelines	18.1 months Interval 15.8 to 22.3	NA months Median and corresponding 95% CI could not be estimated due to low number of participants with an event.

SECONDARY outcome

Timeframe: Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)

Population: Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.

Assessment of response was performed by the investigator according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; an increase of >/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count >/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of >/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by >2 g/dL or to <10 g/dL. Percentages are rounded off.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=46 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=46 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Percentage of Participants With PD or Death as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by Fluorescence In-situ Hybridization (FISH) Test	80.4 percentage of participants	80.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to PD or death, whichever occurred first (up to approximately 8 years 5 months)

Population: Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.

PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the investigator using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; increase of >/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count >/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of >/=50% in platelet or neutrophil count, or hemoglobin level by >2 g/dL or to <10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=46 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=46 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
PFS as Assessed by the Investigator Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test	15.4 months Interval 10.0 to 21.0	47.9 months Interval 37.4 to 59.9

SECONDARY outcome

Timeframe: Baseline up to PD or death, whichever occurred first (up to approximately 3 years)

Population: Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.

Assessment of response was performed by the IRC according to the iwCLL guidelines. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; an increase of >/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count >/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of >/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by >2 g/dL or to <10 g/dL. No new IRC data was generated post the primary analysis.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=46 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=46 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Percentage of Participants With PD or Death as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test	47.8 percentage of participants	19.6 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to PD or death, whichever occurred first (up to approximately 3 years)

Population: Analysis was performed on ITT population participants with 17p deletion as identified by FISH test.

PFS was defined as the time from randomization until first occurrence of PD/relapse as assessed by the IRC using iwCLL guidelines, or death from any cause, whichever occurred first. PD: occurrence of one of the following: new lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; increase of >/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count >/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of >/=50% in platelet or neutrophil count, or hemoglobin level by >2 g/dL or to <10 g/dL. Participants who had not progressed, relapsed, or died at the time of analysis, were censored on the date of last assessment. In case of no disease assessment after baseline, PFS was censored at the time of randomization+1 day. The median PFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. No new IRC data was generated post the primary analysis.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=46 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=46 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
PFS as Assessed by the IRC Using Standard iwCLL Guidelines in Participants With 17p Deletion as Identified by FISH Test	16.1 months Interval 13.6 to 22.3	NA months Interval 27.6 to Median and Upper Limit of 95% CI could not be estimated due to low number of participants with an event.

SECONDARY outcome

Timeframe: Baseline up to approximately 8 years 5 months

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

Response was assessed by investigator according to iwCLL guidelines and was confirmed by repeat assessment >/=4 weeks after initial documentation. CR: peripheral blood lymphocytes <4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with <30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: >/=50% reduction in two of following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and 1 of following: neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL or >/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. 95% CI was computed using Pearson-Clopper method.Percentages are rounded off.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines CR	8.2 percentage of participants Interval 4.76 to 12.98	26.3 percentage of participants Interval 20.24 to 33.07
Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines CRi	0.5 percentage of participants Interval 0.01 to 2.82	1.5 percentage of participants Interval 0.32 to 4.45
Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines nPR	6.2 percentage of participants Interval 3.22 to 10.5	3.6 percentage of participants Interval 1.46 to 7.29
Percentage of Participants With Best Overall Response of Complete Response (CR), CR With Incomplete Bone Marrow Recovery (CRi), Nodular Partial Response (nPR), or Partial Response (PR) as Assessed by the Investigator Using iwCLL Guidelines PR	52.8 percentage of participants Interval 45.56 to 59.99	61.9 percentage of participants Interval 54.62 to 68.72

SECONDARY outcome

Timeframe: Baseline up to last FUV (up to approximately 3 years)

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

Response was assessed by IRC according to iwCLL guidelines and was confirmed by repeat assessment >/=4 weeks after initial documentation. CR: peripheral blood lymphocytes <4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, constitutional symptoms; neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with <30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: >/=50% reduction in 2 of following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; 1 of following: neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL or >/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. 95% CI was computed using Pearson-Clopper method.No new IRC data was generated post primary analysis.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Percentage of Participants With Best Overall Response of CR, CRi, nPR, or PR as Assessed by the IRC Using iwCLL Guidelines	67.7 percentage of participants Interval 60.64 to 74.2	93.3 percentage of participants Interval 88.81 to 96.38

SECONDARY outcome

Timeframe: End of combination treatment response (EoCTR) visit (8 to 12 weeks after Cycle [C] 6 Day [1]); Cycle length = 28 days

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

Response was assessed by investigator according to iwCLL guidelines and was confirmed by repeat assessment >/=4 weeks after initial documentation. CR: peripheral blood lymphocytes <4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with <30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: >/=50% reduction in 2 of following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and 1 of following: neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL or >/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. 95% CI was computed using Pearson-Clopper method. Percentages are rounded off.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Percentage of Participants With Overall Response of CR, Cri, nPR, or PR at End of Combination Treatment Visit as Assessed by the Investigator Using iwCLL Guidelines	63.1 percentage of participants Interval 55.89 to 69.86	88.1 percentage of participants Interval 82.74 to 92.33

SECONDARY outcome

Timeframe: EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

Response was assessed by the IRC according to the iwCLL guidelines and was confirmed by repeat assessment >/=4 weeks after initial documentation. CR: peripheral blood lymphocytes <4000/mcL; absence of any new lesion, nodal disease, lymphadenopathy, hepatomegaly, splenomegaly, and constitutional symptoms; neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL without need for transfusion or exogenous growth factors; normocellular bone marrow with <30% lymphocytes; no lymphoid nodules. CRi: fulfilling all CR criteria but persistent cytopenia. PR: >/=50% reduction in two of the following: peripheral blood lymphocytes, lymphadenopathy, spleen and/or liver enlargement; and one of the following: neutrophils >1500/mcL, platelets >100000/mcL, hemoglobin >11.0 g/dL or >/=50% improvement without need for transfusion or exogenous growth factors. nPR: fulfilling all CR criteria but presence of lymphoid nodules. The 95% CI was computed using Pearson-Clopper method.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Percentage of Participants With Overall Response of CR, Cri, nPR, or PR at End of Combination Treatment Visit as Assessed by the IRC Using iwCLL Guidelines	62.6 percentage of participants Interval 55.37 to 69.37	87.1 percentage of participants Interval 81.57 to 91.48

SECONDARY outcome

Timeframe: Baseline up to approximately 8 years 5 months

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

Percentage of participants who died from any cause, during the study, was reported. Percentage is rounded off.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Percentage of Participants Who Died	43.1 percentage of participants	30.9 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to approximately 8 years 5 months

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

OS was defined as the time from the date of randomization to the date of death from any cause. Participants alive at the time of the analysis were censored at the date when they were last known to be alive as documented by the investigator. The median OS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Overall Survival (OS)	87.8 months Interval 70.1 to Upper limit was not estimable due to low number of participants with event.	NA months Median, lower limit and upper limit were not estimable due to low number of participants with event.

SECONDARY outcome

Timeframe: Baseline up to PD/relapse, start of a new anti-CLL therapy, or death from any cause, whichever occurred first (approximately 8 years 5 months)

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

Percentage of participants with PD/relapse, death from any cause, or start of a new non-protocol-specified anti-CLL therapy as assessed by the investigator, during the study, was reported. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; an increase of >/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count >/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of >/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by >2 g/dL or to <10 g/dL. Percentages are rounded off.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Percentage of Participants With PD/Relapse, Start of a New Anti-Chronic Lymphocytic Leukemia (CLL) Therapy, or Death as Assessed by the Investigator Using iwCLL Guidelines	89.2 percentage of participants	71.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to PD/relapse, start of a new anti-CLL therapy, or death from any cause, whichever occurred first (approximately 8 years 5 months)

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

EFS was defined as the time from date of randomization until the date of PD/relapse, start of a new non-protocol-specified anti-CLL therapy, or death from any cause, whichever occurred first, as assessed by the investigator. PD: occurrence of one of the following: new lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; increase of >/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count >/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of >/=50% in platelet or neutrophil count, or hemoglobin level by >2 g/dL or to <10 g/dL. Participants without any of the specified event at the time of analysis were censored at the date of last adequate response assessment. In case of no post-baseline response assessment, participants were censored at the randomization date. The median EFS was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Event-Free Survival (EFS) as Assessed by the Investigator Using iwCLL Guidelines	16.4 months Interval 14.2 to 21.0	53.7 months Interval 48.5 to 59.3

SECONDARY outcome

Timeframe: From time of achieving best overall response until PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)

Population: Analysis was performed on ITT population participants who had best overall response of CR, CRi, nPR, or PR.

Percentage of participants with PD as assessed by the investigator according to the iwCLL guidelines or death from any cause during the study was reported. PD was defined as occurrence of one of the following events: appearance of any new extra nodal lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; an increase of >/=50% compared to baseline in splenomegaly, hepatomegaly, number of blood lymphocytes with lymphocyte count >/=5000/mcL, or in longest diameter of any extra nodal lesion; transformation to a more aggressive histology; decrease of >/=50% compared to baseline in platelet or neutrophil count; or decrease in hemoglobin level by >2 g/dL or to <10 g/dL. CR, CRi, nPR, and PR have been defined in previous outcomes, and are not repeated here due to space constraint. Percentage is rounded off.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=132 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=181 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Percentage of Participants With PD or Death Among Participants With Best Overall Response of CR, CRi, nPR, or PR as Assessed by the Investigator Using iwCLL Guidelines	95.5 percentage of participants	68.5 percentage of participants

SECONDARY outcome

Timeframe: From time of achieving best overall response until PD or death from any cause, whichever occurred first (up to approximately 8 years 5 months)

Population: Analysis was performed on ITT population participants who had best overall response of CR, CRi, nPR, or PR.

DOR was defined as the time from first occurrence of a documented response of CR, CRi, nPR, or PR until PD/relapse, as assessed by the investigator according to the iwCLL guidelines, or death from any cause. PD: occurrence of one of the following: new lesion; new palpable lymph node (>1.5 cm); unequivocal progression of non-target lesion; increase of >/=50% in splenomegaly, hepatomegaly, blood lymphocytes with count >/=5000/mcL, longest diameter of any lesion; transformation to more aggressive histology; decrease of >/=50% in platelet or neutrophil count, or hemoglobin level by >2 g/dL or to <10 g/dL. Participants without PD or death after response were censored at the last date of adequate response assessment. The median DOR was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley. CR, CRi, nPR, and PR have been defined in previous outcomes, and are not repeated here due to space constraint.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=132 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=181 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Duration of Responses (DOR) as Assessed by the Investigator Using iwCLL Guidelines	19.1 months Interval 16.1 to 23.6	53.6 months Interval 49.1 to 57.0

SECONDARY outcome

Timeframe: Baseline up to start of new ani-CLL therapy or death, whichever occurred first (up to approximately 8 years 5 months)

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

Percentage of participants with start of new non-protocol-specified anti-CLL therapy, as assessed by the investigator, or death from any cause, during the study, was reported. Percentage is rounded off.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Percentage of Participants With Start of New Anti-CLL Treatment or Death as Assessed by the Investigator	81.5 percentage of participants	62.4 percentage of participants

SECONDARY outcome

Timeframe: Baseline up to start of new ani-CLL therapy or death, whichever occurred first (up to approximately 8 years 5 months)

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

TTNT was defined as the time from randomization until start of new non-protocol-specified anti-CLL treatment or death from any cause. Participants without the event at the time of analysis were censored at the last visit date for this outcome measure analysis. The median TTNT was estimated using Kaplan-Meier method and the 95% CI was computed using method of Brookmeyer and Crowley.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Time to New Anti-CLL Treatment (TTNT) as Assessed by the Investigator	24.0 months Interval 20.7 to 29.5	63.0 months Interval 56.1 to 73.6

SECONDARY outcome

Timeframe: EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

MRD-negativity was defined as the presence of <1 malignant B-cell per 10000 normal B-cells in a sample of at least 200000 B-cells, as assessed by the allele specific oligonucleotide polymerase chain reaction (ASO-PCR) and/or flow cytometry technique. Percentage of participants with MRD-negativity was reported. The 95% CI was computed using Pearson-Clopper method. Percentage is rounded off.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Percentage of Participants With Minimal Residual Disease (MRD) Negativity in Peripheral Blood	13.3 percentage of participants Interval 8.9 to 18.92	62.4 percentage of participants Interval 55.15 to 69.21

SECONDARY outcome

Timeframe: EoCTR visit (8 to 12 weeks after C6D1); Cycle length = 28 days

Population: ITT population included all randomized participants, with participants grouped according to randomized treatment group, regardless of the actual treatment received.

MRD-negativity was defined as the presence of <1 malignant B-cell per 10000 normal B-cells in a sample of at least 200000 B-cells, as assessed flow cytometry technique. Percentage of participants with MRD-negativity was reported. The 95% CI was computed using Pearson-Clopper method. Percentages are rounded off.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=195 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Percentage of Participants With MRD Negativity in Bone Marrow	1.0 percentage of participants Interval 0.12 to 3.66	14.4 percentage of participants Interval 9.81 to 20.18

SECONDARY outcome

Timeframe: Pre-dose (0 hour, anytime before venetoclax administration) and 4 hours post-dose on D1 of Cycles 1 and 4; Cycle length = 28 days

Population: Pharmacokinetic (PK) evaluable population included all participants in the 'Venetoclax + Rituximab' arm who received at least one dose of venetoclax with at least one post-dose PK concentration result available. Here 'Number Analyzed' signifies the number of participants evaluable at specified time point.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=184 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Plasma Venetoclax Concentrations C1D1, Pre-dose	0.626 micrograms per milliliter (mcg/mL) Standard Deviation 0.540	—
Plasma Venetoclax Concentrations C1D1, 4 hours Post-Dose	1.34 micrograms per milliliter (mcg/mL) Standard Deviation 0.881	—
Plasma Venetoclax Concentrations C4D1, Pre-dose	0.681 micrograms per milliliter (mcg/mL) Standard Deviation 0.745	—
Plasma Venetoclax Concentrations C4D1, 4 hours Post-Dose	1.34 micrograms per milliliter (mcg/mL) Standard Deviation 0.905	—

SECONDARY outcome

Timeframe: Baseline, Days 1, 8, and 15 of Cycles 1, 2, and 3; Cycle length = 28 days

Population: Patient reported outcomes (PRO) evaluable population included all participants with baseline and at least one post-baseline PRO assessment. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable at specified time point.

MDASI is a 25-item validated questionnaire consisting of 2 parts. Part 1: 19-items divided into 2 scales, Core Symptom Severity (average of Questions 1 to 13; total 13 items: pain, fatigue, nausea, disturbed sleep, distress, shortness of breath, remembering things, lack of appetite, drowsiness, dry mouth, sadness, vomiting, and numbness) and Module Symptom Severity (average of Questions 14 to 19; total 6 items: night sweats, fevers and chills, lymph node swelling, diarrhea, bruising easy or bleeding, and constipation). Part 2: 6-items to assess Interference (symptom distress) (average of Questions 20 to 25; total 6 items: general activity, walking, work, mood, relations with other people, and enjoyment of life). Each item was rated from 0 to 10, with lower scores indicating better outcome. Total score for Core Symptom Severity, Module Symptom Severity, and Interference are reported which range from 0 to 10, with lower scores indicating better health-related quality of life (HRQoL).

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=117 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=42 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Baseline; Mean core symptom severity	1.76 units on a scale Standard Deviation 1.55	1.55 units on a scale Standard Deviation 1.31
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C1D1; Mean core symptom severity	0.00 units on a scale Standard Deviation 0.00	-0.08 units on a scale Standard Deviation 0.98
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C1D8; Mean core symptom severity	0.26 units on a scale Standard Deviation 1.34	-0.30 units on a scale Standard Deviation 0.84
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C1D15; Mean core symptom severity	0.00 units on a scale Standard Deviation 1.31	-0.27 units on a scale Standard Deviation 0.93
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C2D1; Mean core symptom severity	-0.23 units on a scale Standard Deviation 1.30	-0.33 units on a scale Standard Deviation 0.91
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C2D8; Mean core symptom severity	0.17 units on a scale Standard Deviation 1.59	-0.45 units on a scale Standard Deviation 0.91
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C2D15; Mean core symptom severity	-0.13 units on a scale Standard Deviation 1.53	-0.53 units on a scale Standard Deviation 0.90
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C3D1; Mean core symptom severity	-0.26 units on a scale Standard Deviation 1.60	-0.40 units on a scale Standard Deviation 1.13
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C3D8; Mean core symptom severity	-0.13 units on a scale Standard Deviation 1.63	-0.66 units on a scale Standard Deviation 1.20
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C3D15; Mean core symptom severity	-0.42 units on a scale Standard Deviation 1.52	-0.53 units on a scale Standard Deviation 1.05
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Baseline; Mean module symptom severity	1.60 units on a scale Standard Deviation 1.46	1.57 units on a scale Standard Deviation 1.11
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C1D1; Mean module symptom severity	0.00 units on a scale Standard Deviation 0.00	-0.19 units on a scale Standard Deviation 0.96
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C1D8; Mean module symptom severity	-0.22 units on a scale Standard Deviation 1.40	-0.53 units on a scale Standard Deviation 0.96
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C1D15; Mean module symptom severity	-0.43 units on a scale Standard Deviation 1.51	-0.73 units on a scale Standard Deviation 1.13
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C2D1; Mean module symptom severity	-0.49 units on a scale Standard Deviation 1.46	-0.65 units on a scale Standard Deviation 0.92
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C2D8; Mean module symptom severity	-0.46 units on a scale Standard Deviation 1.63	-0.77 units on a scale Standard Deviation 0.87
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C2D15; Mean module symptom severity	-0.69 units on a scale Standard Deviation 1.47	-0.94 units on a scale Standard Deviation 0.93
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C3D1; Mean module symptom severity	-0.65 units on a scale Standard Deviation 1.48	-0.81 units on a scale Standard Deviation 0.97
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C3D8; Mean module symptom severity	-0.51 units on a scale Standard Deviation 1.58	-0.83 units on a scale Standard Deviation 0.97
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C3D15; Mean module symptom severity	-0.83 units on a scale Standard Deviation 1.51	-0.92 units on a scale Standard Deviation 0.97
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Baseline; Mean interference	1.81 units on a scale Standard Deviation 2.05	1.90 units on a scale Standard Deviation 2.25
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C1D1; Mean interference	0.00 units on a scale Standard Deviation 0.00	-0.13 units on a scale Standard Deviation 1.49
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C1D8; Mean interference	0.45 units on a scale Standard Deviation 1.78	-0.29 units on a scale Standard Deviation 2.14
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C1D15; Mean interference	0.36 units on a scale Standard Deviation 1.85	0.01 units on a scale Standard Deviation 2.04
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C2D1; Mean interference	0.01 units on a scale Standard Deviation 1.73	-0.34 units on a scale Standard Deviation 1.78
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C2D8; Mean interference	0.58 units on a scale Standard Deviation 2.20	-0.58 units on a scale Standard Deviation 1.81
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C2D15; Mean interference	0.06 units on a scale Standard Deviation 1.84	-0.64 units on a scale Standard Deviation 1.59
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C3D1; Mean interference	-0.02 units on a scale Standard Deviation 2.02	-0.73 units on a scale Standard Deviation 2.06
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C3D8; Mean interference	0.15 units on a scale Standard Deviation 1.91	-0.82 units on a scale Standard Deviation 2.09
Change From Baseline in Monroe Dunaway (MD) Anderson Symptom Inventory (MDASI) Core Symptom Severity, Module Symptom Severity, and Interference Scores Change at C3D15; Mean interference	-0.07 units on a scale Standard Deviation 2.01	-0.55 units on a scale Standard Deviation 2.18

SECONDARY outcome

Timeframe: Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days

Population: Patient reported outcome (PRO) evaluable population included all participants with baseline and at least one post-baseline PRO assessment. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable at specified time point.

EORTC QLQ-C30 is a validated self-report measure consisting of 30 questions incorporated into 5 functional scales (Physical, Role, Cognitive, Emotional, and Social), 3 symptom scales (fatigue, pain, nausea, and vomiting), a global health status/global QoL scale, and single items (dyspnea, appetite loss, sleep disturbance, constipation, and diarrhea). Most questions used 4-point scale (1='Not at all' to 4='Very much'), while 2 questions used 7-point scale (1='very poor' to 7='Excellent'). Scores were averaged, transformed to 0-100 scale; where higher score for functional scales=poor level of functioning; higher score for global health status/global QoL=better HRQoL.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=177 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=69 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Baseline; Global health status/QoL	63.02 units on a scale Standard Deviation 21.45	67.39 units on a scale Standard Deviation 22.17
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C1D1; Global health status/QoL	0.0 units on a scale Standard Deviation 0.0	6.34 units on a scale Standard Deviation 18.41
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Baseline; Physical functioning	82.59 units on a scale Standard Deviation 17.46	83.77 units on a scale Standard Deviation 15.27
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C1D1; Physical functioning	0.0 units on a scale Standard Deviation 0.0	1.39 units on a scale Standard Deviation 12.90
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C2D1; Physical functioning	0.31 units on a scale Standard Deviation 15.81	2.99 units on a scale Standard Deviation 12.83
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C3D1; Physical functioning	0.22 units on a scale Standard Deviation 16.43	1.46 units on a scale Standard Deviation 14.76
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C4D1; Physical functioning	2.11 units on a scale Standard Deviation 14.95	5.54 units on a scale Standard Deviation 14.17
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C5D1; Physical functioning	2.44 units on a scale Standard Deviation 18.19	4.62 units on a scale Standard Deviation 15.27
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C6D1; Physical functioning	2.25 units on a scale Standard Deviation 16.82	4.51 units on a scale Standard Deviation 16.59
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at STC/EW; Physical functioning	1.68 units on a scale Standard Deviation 18.76	4.53 units on a scale Standard Deviation 16.04
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at EoCTR; Physical functioning	2.92 units on a scale Standard Deviation 18.03	4.34 units on a scale Standard Deviation 16.12
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV1; Physical functioning	2.27 units on a scale Standard Deviation 18.86	3.81 units on a scale Standard Deviation 16.27
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV2; Physical functioning	2.40 units on a scale Standard Deviation 19.21	2.75 units on a scale Standard Deviation 17.17
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV3; Physical functioning	2.54 units on a scale Standard Deviation 17.83	3.44 units on a scale Standard Deviation 17.31
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV4; Physical functioning	4.74 units on a scale Standard Deviation 20.14	0.85 units on a scale Standard Deviation 21.06
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV5; Physical functioning	1.90 units on a scale Standard Deviation 17.68	-1.75 units on a scale Standard Deviation 19.35
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV6; Physical functioning	-1.41 units on a scale Standard Deviation 15.34	1.33 units on a scale Standard Deviation 5.58
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV7; Physical functioning	-3.08 units on a scale Standard Deviation 11.74	0.00 units on a scale
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV8; Physical functioning	-9.33 units on a scale Standard Deviation 23.38	0.00 units on a scale
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV9; Physical functioning	-10.00 units on a scale Standard Deviation 33.0	—
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Baseline; Role functioning	78.25 units on a scale Standard Deviation 25.67	83.82 units on a scale Standard Deviation 21.00
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C1D1; Role functioning	0.0 units on a scale Standard Deviation 0.0	-1.74 units on a scale Standard Deviation 23.23
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C2D1; Role functioning	-1.26 units on a scale Standard Deviation 27.45	2.49 units on a scale Standard Deviation 23.07
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C3D1; Role functioning	-0.10 units on a scale Standard Deviation 29.64	1.82 units on a scale Standard Deviation 26.08
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C4D1; Role functioning	0.87 units on a scale Standard Deviation 29.01	5.13 units on a scale Standard Deviation 22.03
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C5D1; Role functioning	0.45 units on a scale Standard Deviation 30.75	4.36 units on a scale Standard Deviation 23.44
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C6D1; Role functioning	0.70 units on a scale Standard Deviation 29.92	1.79 units on a scale Standard Deviation 25.71
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at STC/EW; Role functioning	-0.41 units on a scale Standard Deviation 32.91	2.60 units on a scale Standard Deviation 25.58
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at EoCTR; Role functioning	3.26 units on a scale Standard Deviation 29.95	2.12 units on a scale Standard Deviation 26.69
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV1; Role functioning	2.93 units on a scale Standard Deviation 32.31	2.65 units on a scale Standard Deviation 27.47
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV2; Role functioning	3.07 units on a scale Standard Deviation 32.63	-1.85 units on a scale Standard Deviation 31.84
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV3; Role functioning	5.26 units on a scale Standard Deviation 31.16	1.88 units on a scale Standard Deviation 28.17
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV4; Role functioning	5.41 units on a scale Standard Deviation 33.16	-0.35 units on a scale Standard Deviation 30.39
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV5; Role functioning	2.34 units on a scale Standard Deviation 29.79	1.75 units on a scale Standard Deviation 34.20
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV6; Role functioning	-4.04 units on a scale Standard Deviation 27.01	-13.33 units on a scale Standard Deviation 32.06
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV7; Role functioning	2.56 units on a scale Standard Deviation 29.54	-16.67 units on a scale
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV8; Role functioning	0.00 units on a scale Standard Deviation 23.57	16.67 units on a scale
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV9; Role functioning	-16.67 units on a scale Standard Deviation 23.57	—
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Baseline; Emotional functioning	78.98 units on a scale Standard Deviation 22.47	82.13 units on a scale Standard Deviation 15.80
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C1D1; Emotional functioning	0.0 units on a scale Standard Deviation 0.0	4.35 units on a scale Standard Deviation 15.17
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C2D1; Emotional functioning	2.24 units on a scale Standard Deviation 20.07	5.60 units on a scale Standard Deviation 14.68
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C3D1; Emotional functioning	2.99 units on a scale Standard Deviation 20.06	5.34 units on a scale Standard Deviation 19.09
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C4D1; Emotional functioning	2.61 units on a scale Standard Deviation 18.35	4.19 units on a scale Standard Deviation 15.45
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C5D1; Emotional functioning	1.14 units on a scale Standard Deviation 18.79	3.97 units on a scale Standard Deviation 17.37
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C6D1; Emotional functioning	2.06 units on a scale Standard Deviation 18.74	3.08 units on a scale Standard Deviation 17.96
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at STC/EW; Emotional functioning	2.43 units on a scale Standard Deviation 20.61	5.34 units on a scale Standard Deviation 18.69
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at EoCTR; Emotional functioning	2.58 units on a scale Standard Deviation 19.45	3.49 units on a scale Standard Deviation 17.83
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV1; Emotional functioning	3.49 units on a scale Standard Deviation 20.91	4.37 units on a scale Standard Deviation 18.50
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV2; Emotional functioning	4.39 units on a scale Standard Deviation 20.33	0.66 units on a scale Standard Deviation 21.02
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV3; Emotional functioning	0.63 units on a scale Standard Deviation 19.97	2.82 units on a scale Standard Deviation 17.66
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV4; Emotional functioning	4.82 units on a scale Standard Deviation 19.73	1.95 units on a scale Standard Deviation 18.41
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV5; Emotional functioning	3.13 units on a scale Standard Deviation 17.95	2.63 units on a scale Standard Deviation 20.61
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV6; Emotional functioning	2.27 units on a scale Standard Deviation 21.78	5.00 units on a scale Standard Deviation 17.28
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV7; Emotional functioning	5.77 units on a scale Standard Deviation 17.48	-8.33 units on a scale
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV8; Emotional functioning	3.33 units on a scale Standard Deviation 28.01	0.00 units on a scale
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV9; Emotional functioning	-16.67 units on a scale Standard Deviation 11.79	—
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Baseline; Cognitive functioning	86.55 units on a scale Standard Deviation 16.78	89.86 units on a scale Standard Deviation 14.91
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C1D1; Cognitive functioning	0.0 units on a scale Standard Deviation 0.0	-1.24 units on a scale Standard Deviation 14.01
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C2D1; Cognitive functioning	-0.19 units on a scale Standard Deviation 15.34	0.25 units on a scale Standard Deviation 14.06
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C3D1; Cognitive functioning	-0.32 units on a scale Standard Deviation 16.34	-1.56 units on a scale Standard Deviation 17.50
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C4D1; Cognitive functioning	-1.54 units on a scale Standard Deviation 17.41	-0.26 units on a scale Standard Deviation 17.05
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C5D1; Cognitive functioning	-1.94 units on a scale Standard Deviation 18.10	-0.26 units on a scale Standard Deviation 14.28
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C6D1; Cognitive functioning	-2.68 units on a scale Standard Deviation 16.97	-0.77 units on a scale Standard Deviation 15.98
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at STC/EW; Cognitive functioning	-2.19 units on a scale Standard Deviation 17.65	1.04 units on a scale Standard Deviation 18.28
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at EoCTR; Cognitive functioning	-2.23 units on a scale Standard Deviation 18.11	-0.27 units on a scale Standard Deviation 16.94
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV1; Cognitive functioning	-2.02 units on a scale Standard Deviation 17.21	-0.26 units on a scale Standard Deviation 15.98
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV2; Cognitive functioning	1.32 units on a scale Standard Deviation 16.16	-2.38 units on a scale Standard Deviation 18.17
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV3; Cognitive functioning	-1.63 units on a scale Standard Deviation 14.84	-2.96 units on a scale Standard Deviation 18.24
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV4; Cognitive functioning	0.44 units on a scale Standard Deviation 17.63	-1.77 units on a scale Standard Deviation 19.11
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV5; Cognitive functioning	-1.49 units on a scale Standard Deviation 15.66	-6.14 units on a scale Standard Deviation 21.67
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV6; Cognitive functioning	-0.51 units on a scale Standard Deviation 14.72	0.00 units on a scale Standard Deviation 0.00
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV7; Cognitive functioning	-1.28 units on a scale Standard Deviation 14.37	0.00 units on a scale
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV8; Cognitive functioning	0.00 units on a scale Standard Deviation 23.57	0.00 units on a scale
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV9; Cognitive functioning	16.67 units on a scale Standard Deviation 23.57	—
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Baseline; Social functioning	82.48 units on a scale Standard Deviation 22.06	85.51 units on a scale Standard Deviation 21.18
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C1D1; Social functioning	0.0 units on a scale Standard Deviation 0.0	-1.74 units on a scale Standard Deviation 19.92
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C2D1; Social functioning	-2.44 units on a scale Standard Deviation 21.44	0.25 units on a scale Standard Deviation 18.46
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C3D1; Social functioning	-2.32 units on a scale Standard Deviation 22.61	3.65 units on a scale Standard Deviation 25.45
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C4D1; Social functioning	-0.55 units on a scale Standard Deviation 22.15	4.62 units on a scale Standard Deviation 20.09
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C5D1; Social functioning	-5.48 units on a scale Standard Deviation 26.49	2.56 units on a scale Standard Deviation 20.46
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C6D1; Social functioning	-5.13 units on a scale Standard Deviation 24.80	3.85 units on a scale Standard Deviation 24.61
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at STC/EW; Social functioning	-4.06 units on a scale Standard Deviation 27.71	1.04 units on a scale Standard Deviation 19.22
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at EoCTR; Social functioning	-0.47 units on a scale Standard Deviation 24.95	1.88 units on a scale Standard Deviation 20.49
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV1; Social functioning	-1.08 units on a scale Standard Deviation 26.09	1.59 units on a scale Standard Deviation 24.27
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV2; Social functioning	0.58 units on a scale Standard Deviation 24.68	1.32 units on a scale Standard Deviation 27.97
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV3; Social functioning	-0.91 units on a scale Standard Deviation 24.00	1.88 units on a scale Standard Deviation 25.98
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV4; Social functioning	1.97 units on a scale Standard Deviation 27.35	1.06 units on a scale Standard Deviation 32.12
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV5; Social functioning	1.79 units on a scale Standard Deviation 26.72	0.00 units on a scale Standard Deviation 33.79
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV6; Social functioning	1.52 units on a scale Standard Deviation 29.27	10.00 units on a scale Standard Deviation 14.91
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV7; Social functioning	-2.56 units on a scale Standard Deviation 23.42	33.33 units on a scale
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV8; Social functioning	-10.00 units on a scale Standard Deviation 22.36	33.33 units on a scale
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV9; Social functioning	-25.00 units on a scale Standard Deviation 35.36	—
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C2D1; Global health status/QoL	2.73 units on a scale Standard Deviation 21.69	5.35 units on a scale Standard Deviation 20.14
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C3D1; Global health status/QoL	2.34 units on a scale Standard Deviation 24.66	2.21 units on a scale Standard Deviation 23.58
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C4D1; Global health status/QoL	3.84 units on a scale Standard Deviation 22.26	7.05 units on a scale Standard Deviation 21.05
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C5D1; Global health status/QoL	7.36 units on a scale Standard Deviation 24.20	7.18 units on a scale Standard Deviation 21.94
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at C6D1; Global health status/QoL	4.25 units on a scale Standard Deviation 25.00	5.90 units on a scale Standard Deviation 25.16
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at STC/EW; Global health status/QoL	4.32 units on a scale Standard Deviation 26.20	6.51 units on a scale Standard Deviation 23.22
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at EoCTR; Global health status/QoL	6.10 units on a scale Standard Deviation 23.65	7.66 units on a scale Standard Deviation 24.11
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV1; Global health status/QoL	5.91 units on a scale Standard Deviation 24.57	7.01 units on a scale Standard Deviation 25.01
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV2; Global health status/QoL	6.94 units on a scale Standard Deviation 24.81	4.50 units on a scale Standard Deviation 26.51
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV3; Global health status/QoL	4.80 units on a scale Standard Deviation 25.30	6.32 units on a scale Standard Deviation 27.36
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV4; Global health status/QoL	7.35 units on a scale Standard Deviation 26.77	6.38 units on a scale Standard Deviation 27.60
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV5; Global health status/QoL	4.46 units on a scale Standard Deviation 23.89	4.39 units on a scale Standard Deviation 18.08
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV6; Global health status/QoL	1.01 units on a scale Standard Deviation 24.00	5.00 units on a scale Standard Deviation 7.45
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV7; Global health status/QoL	8.33 units on a scale Standard Deviation 25.69	16.67 units on a scale
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV8; Global health status/QoL	6.67 units on a scale Standard Deviation 16.03	8.33 units on a scale
Change From Baseline in HRQoL as Measured by European Organization for Research and Treatment of Cancer Core Quality of Life Questionnaire (EORTC QLQ-C30) Functional Scales Score and Global Health Status/Global Quality-of-Life (QoL) Scale Score Change at FUV9; Global health status/QoL	0.00 units on a scale Standard Deviation 0.00	—

SECONDARY outcome

Timeframe: Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days

Population: PRO evaluable population included all participants with baseline and at least one post-baseline PRO assessment. Here, 'Overall Number of Participants Analyzed' = participants evaluable for this outcome measure and 'Number Analyzed' = participants evaluable at specified time point.

The EORTC QLQ-CLL16 module is designed for participants with Stage 0 to Stage 4 CLL. It is composed of 16 questions and there are four multi-item scales on Fatigue (2 items), Treatment-related side effects (TRSE, 4 items), Disease-related symptoms (DRS, 4 items), and Infection (4 items); and two single-item scales on social activities and future health worries. Multi-item scales score are reported and the total score for each multi-item scale was transformed to result in a total score range of 0 to 100, where higher score = poor HRQoL.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=175 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=69 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Baseline; TRSE	14.29 units on a scale Standard Deviation 13.95	9.42 units on a scale Standard Deviation 8.80
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C1D1; TRSE	0.0 units on a scale Standard Deviation 0.0	0.12 units on a scale Standard Deviation 10.10
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C2D1; TRSE	1.62 units on a scale Standard Deviation 13.82	0.62 units on a scale Standard Deviation 12.76
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C3D1; TRSE	-0.26 units on a scale Standard Deviation 13.76	1.98 units on a scale Standard Deviation 14.72
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C4D1; TRSE	-0.49 units on a scale Standard Deviation 13.97	0.52 units on a scale Standard Deviation 11.87
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C5D1; TRSE	-0.51 units on a scale Standard Deviation 14.57	0.64 units on a scale Standard Deviation 10.02
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C6D1; TRSE	0.46 units on a scale Standard Deviation 15.51	-0.13 units on a scale Standard Deviation 10.04
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at STC/EW; TRSE	0.81 units on a scale Standard Deviation 18.11	0.13 units on a scale Standard Deviation 10.76
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at EoCTR; TRSE	-0.88 units on a scale Standard Deviation 16.06	0.26 units on a scale Standard Deviation 12.61
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV1; TRSE	-1.20 units on a scale Standard Deviation 14.87	1.19 units on a scale Standard Deviation 12.24
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV2; TRSE	-1.70 units on a scale Standard Deviation 15.28	2.65 units on a scale Standard Deviation 14.03
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV3; TRSE	-2.08 units on a scale Standard Deviation 12.64	-0.13 units on a scale Standard Deviation 13.70
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV4; TRSE	-1.97 units on a scale Standard Deviation 12.76	2.84 units on a scale Standard Deviation 15.18
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV5; TRSE	-2.68 units on a scale Standard Deviation 11.02	1.32 units on a scale Standard Deviation 10.49
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV6; TRSE	-1.01 units on a scale Standard Deviation 12.10	-1.67 units on a scale Standard Deviation 3.73
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV7; TRSE	2.56 units on a scale Standard Deviation 22.67	-8.33 units on a scale
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV8; TRSE	1.67 units on a scale Standard Deviation 13.69	0.00 units on a scale
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV9; TRSE	8.33 units on a scale Standard Deviation 11.79	—
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Baseline; DRS	19.57 units on a scale Standard Deviation 16.81	16.95 units on a scale Standard Deviation 17.37
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C1D1; DRS	0.0 units on a scale Standard Deviation 0.0	-2.74 units on a scale Standard Deviation 16.18
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C2D1; DRS	-3.33 units on a scale Standard Deviation 16.05	-4.77 units on a scale Standard Deviation 16.84
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C3D1; DRS	-4.77 units on a scale Standard Deviation 16.49	-3.35 units on a scale Standard Deviation 17.48
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C4D1; DRS	-6.03 units on a scale Standard Deviation 16.51	-5.12 units on a scale Standard Deviation 17.72
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C5D1; DRS	-5.90 units on a scale Standard Deviation 16.73	-4.79 units on a scale Standard Deviation 17.50
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C6D1; DRS	-6.40 units on a scale Standard Deviation 17.26	-5.30 units on a scale Standard Deviation 16.72
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at STC/EW; DRS	-5.80 units on a scale Standard Deviation 18.52	-6.51 units on a scale Standard Deviation 18.45
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at EoCTR; DRS	-6.57 units on a scale Standard Deviation 17.21	-5.86 units on a scale Standard Deviation 20.38
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV1; DRS	-6.55 units on a scale Standard Deviation 15.73	-5.82 units on a scale Standard Deviation 19.20
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV2; DRS	-8.63 units on a scale Standard Deviation 14.39	-3.57 units on a scale Standard Deviation 18.31
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV3; DRS	-7.37 units on a scale Standard Deviation 14.88	-3.76 units on a scale Standard Deviation 19.25
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV4; DRS	-8.55 units on a scale Standard Deviation 18.56	-2.66 units on a scale Standard Deviation 20.49
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV5; DRS	-8.33 units on a scale Standard Deviation 16.13	-2.19 units on a scale Standard Deviation 19.41
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV6; DRS	-6.31 units on a scale Standard Deviation 16.01	-3.33 units on a scale Standard Deviation 13.94
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV7; DRS	-15.38 units on a scale Standard Deviation 20.08	-8.33 units on a scale
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV8; DRS	-10.00 units on a scale Standard Deviation 16.03	-8.33 units on a scale
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV9; DRS	-4.17 units on a scale Standard Deviation 5.89	—
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Baseline; Fatigue	28.76 units on a scale Standard Deviation 24.66	21.74 units on a scale Standard Deviation 20.67
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C1D1; Fatigue	0.0 units on a scale Standard Deviation 0.0	-2.24 units on a scale Standard Deviation 20.29
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C2D1; Fatigue	-2.55 units on a scale Standard Deviation 22.86	-5.47 units on a scale Standard Deviation 21.40
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C3D1; Fatigue	-2.83 units on a scale Standard Deviation 25.17	-3.17 units on a scale Standard Deviation 23.73
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C4D1; Fatigue	-3.18 units on a scale Standard Deviation 23.23	-4.17 units on a scale Standard Deviation 22.02
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C5D1; Fatigue	-2.38 units on a scale Standard Deviation 27.52	-4.36 units on a scale Standard Deviation 20.89
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C6D1; Fatigue	-2.66 units on a scale Standard Deviation 26.35	-2.31 units on a scale Standard Deviation 21.42
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at STC/EW; Fatigue	-3.11 units on a scale Standard Deviation 28.64	-4.69 units on a scale Standard Deviation 21.30
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at EoCTR; Fatigue	-6.69 units on a scale Standard Deviation 26.78	-3.97 units on a scale Standard Deviation 24.27
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV1; Fatigue	-6.37 units on a scale Standard Deviation 26.61	-4.23 units on a scale Standard Deviation 22.99
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV2; Fatigue	-6.64 units on a scale Standard Deviation 24.55	-1.85 units on a scale Standard Deviation 24.70
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV3; Fatigue	-5.79 units on a scale Standard Deviation 23.29	-2.42 units on a scale Standard Deviation 23.73
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV4; Fatigue	-9.65 units on a scale Standard Deviation 26.84	-0.35 units on a scale Standard Deviation 25.18
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV5; Fatigue	-6.55 units on a scale Standard Deviation 25.56	3.51 units on a scale Standard Deviation 23.95
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV6; Fatigue	-5.05 units on a scale Standard Deviation 24.82	3.33 units on a scale Standard Deviation 24.72
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV7; Fatigue	-10.26 units on a scale Standard Deviation 30.08	-33.33 units on a scale
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV8; Fatigue	-6.67 units on a scale Standard Deviation 19.00	0.00 units on a scale
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV9; Fatigue	-8.33 units on a scale Standard Deviation 11.79	—
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Baseline; Infection	15.92 units on a scale Standard Deviation 17.63	14.01 units on a scale Standard Deviation 18.99
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C1D1; Infection	0.0 units on a scale Standard Deviation 0.0	-2.24 units on a scale Standard Deviation 20.03
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C2D1; Infection	-0.02 units on a scale Standard Deviation 19.98	-3.61 units on a scale Standard Deviation 21.72
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C3D1; Infection	-1.66 units on a scale Standard Deviation 19.21	-1.32 units on a scale Standard Deviation 20.48
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C4D1; Infection	-1.44 units on a scale Standard Deviation 22.07	-3.13 units on a scale Standard Deviation 21.28
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C5D1; Infection	-1.91 units on a scale Standard Deviation 24.00	-2.56 units on a scale Standard Deviation 23.47
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at C6D1; Infection	-1.09 units on a scale Standard Deviation 20.66	-2.95 units on a scale Standard Deviation 20.54
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at STC/EW; Infection	-0.12 units on a scale Standard Deviation 23.28	-1.69 units on a scale Standard Deviation 23.34
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at EoCTR; Infection	-0.55 units on a scale Standard Deviation 21.73	-3.44 units on a scale Standard Deviation 25.78
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV1; Infection	1.08 units on a scale Standard Deviation 18.77	-2.65 units on a scale Standard Deviation 26.51
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV2; Infection	0.05 units on a scale Standard Deviation 23.29	-0.53 units on a scale Standard Deviation 25.74
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV3; Infection	-1.90 units on a scale Standard Deviation 16.97	-0.54 units on a scale Standard Deviation 26.48
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV4; Infection	-4.24 units on a scale Standard Deviation 16.71	0.53 units on a scale Standard Deviation 25.56
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV5; Infection	-4.51 units on a scale Standard Deviation 22.66	7.46 units on a scale Standard Deviation 27.20
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV6; Infection	-1.60 units on a scale Standard Deviation 18.90	8.33 units on a scale Standard Deviation 15.59
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV7; Infection	-0.43 units on a scale Standard Deviation 21.84	-16.67 units on a scale
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV8; Infection	8.89 units on a scale Standard Deviation 23.36	-25.00 units on a scale
Change From Baseline in HRQoL as Measured by Quality of Life Questionnaire Associated CLL Module (QLQ-CLL16) Multi-Item Scales Score Change at FUV9; Infection	-2.78 units on a scale Standard Deviation 3.93	—

SECONDARY outcome

Timeframe: From signing of informed consent form up to approximately 8 years 5 months

Population: SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.

An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A Serious Adverse Event (SAE) is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above. AEs were assessed using National Cancer Institute Common Terminology Criteria for Adverse Events, version 4.0 (NCI CTCAE, v4.0)

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=188 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Adverse Events	185 Participants	194 Participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) Serious Adverse Events	84 Participants	101 Participants

SECONDARY outcome

Timeframe: From signing of informed consent form up to approximately 8 years 5 months

Population: SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.

An AE was defined as any untoward medical occurrence in a participant administered with Mircera and which does not necessarily have a causal relationship with Mircera. A SAE is any significant hazard, contraindication, side effect that is fatal or life threatening; requires in-patient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; is medically significant or requires intervention to prevent one or other of the outcomes listed above. TLS and IRRs were graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE v4.0). Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe or medically significant; Grade 4 = Life-threatening; Grade 5 = Death. A higher grade indicates a worse outcome.

Outcome measures

Measure	Bendamustine + Rituximab Main Study n=188 Participants Participants received bendamustine at a dose of 70 milligrams per meter square (mg/m\^2) via intravenous (IV) infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 Participants Participants were initially placed on a venetoclax ramp-up period of 5 weeks and received an initial dose of 20 mg via tablet orally once daily (QD) for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg, orally, QD. Participants continued receiving venetoclax at a dose of 400 mg, orally, QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.
Number of Participants With Grade 3 or Higher Tumor Lysis Syndrome (TLS) and Infusion-related Reactions (IRRs) TLS	2 Participants	6 Participants
Number of Participants With Grade 3 or Higher Tumor Lysis Syndrome (TLS) and Infusion-related Reactions (IRRs) IRRs	10 Participants	4 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, C4D14-28, Study Treatment Completion/Early Withdrawal (STC/EW, up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and at FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days

Outcome measures

Outcome data not reported

POST_HOC outcome

Timeframe: Baseline, D1 of Cycles 1, 2, 3, 4, 5, 6, STC/EW visit (up to C6D28), EoCTR visit (8 to 12 weeks after C6D1), and FUVs (every 12 weeks after EoCTR up to 3 years); Cycle length = 28 days

Outcome measures

Outcome data not reported

Adverse Events

Bendamustine + Rituximab Main Study

Serious events: 84 serious events

Other events: 177 other events

Deaths: 84 deaths

Venetoclax + Rituximab Main Study

Serious events: 101 serious events

Other events: 190 other events

Deaths: 60 deaths

Bendamustine + Rituximab Crossover Substudy

Serious events: 5 serious events

Other events: 5 other events

Deaths: 1 deaths

Venetoclax + Rituximab Re-Treatment Substudy

Serious events: 13 serious events

Other events: 9 other events

Deaths: 8 deaths

Serious adverse events

Measure	Bendamustine + Rituximab Main Study n=188 participants at risk Participants received bendamustine at a dose of 70 mg/m\^2 via IV infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 participants at risk Participants were initially placed on a venetoclax ramp-up period of 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet orally QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Bendamustine + Rituximab Crossover Substudy n=9 participants at risk Participants who entered the crossover substudy had a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, participants received 6 cycles of rituximab, 375 mg/m\^2, as IV infusion on the Day 1 of each 28-day cycle. Participants who did not progress following the completion of the 6 cycles continued to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 crossover Day 1 of the substudy.	Venetoclax + Rituximab Re-Treatment Substudy n=25 participants at risk Participants who entered the re-treatment substudy had a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, participants received 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants who did not progress following the completion of the 6 cycles continued to receive venetoclax monotherapy until disease progression or for a maximum of 2 year from Cycle 1 re-treatment Day 1 of the substudy.
Blood and lymphatic system disorders Anaemia	2.7% 5/188 • Number of events 6 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.5% 3/194 • Number of events 4 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Blood and lymphatic system disorders Autoimmune haemolytic anaemia	1.6% 3/188 • Number of events 4 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.5% 3/194 • Number of events 3 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Blood and lymphatic system disorders Disseminated intravascular coagulation	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Blood and lymphatic system disorders Febrile neutropenia	8.5% 16/188 • Number of events 16 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	3.6% 7/194 • Number of events 7 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Blood and lymphatic system disorders Leukocytosis	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Blood and lymphatic system disorders Neutropenia	1.6% 3/188 • Number of events 3 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.5% 3/194 • Number of events 4 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Blood and lymphatic system disorders Pancytopenia	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Blood and lymphatic system disorders Thrombocytopenia	1.1% 2/188 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.0% 2/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Cardiac disorders Acute myocardial infarction	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Cardiac disorders Angina pectoris	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Cardiac disorders Atrial fibrillation	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Cardiac disorders Cardiac failure	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Cardiac disorders Coronary artery disease	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Cardiac disorders Myocardial infarction	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.0% 2/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Cardiac disorders Ventricular tachycardia	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Ear and labyrinth disorders Deafness	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Ear and labyrinth disorders Vertigo	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Eye disorders Eye haemorrhage	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Abdominal pain	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Anal fistula	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Ascites	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Colitis	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Crohn's disease	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Diarrhoea	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.0% 2/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Dyspepsia	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Nausea	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Oesophageal obstruction	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Vomiting	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Abscess neck	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Appendicitis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.0% 2/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Atypical pneumonia	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Bronchitis	1.1% 2/188 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Bronchopulmonary aspergillosis	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Campylobacter gastroenteritis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Cellulitis	0.53% 1/188 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Clostridium difficile colitis	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Cystitis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Diverticulitis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Erysipelas	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Escherichia sepsis	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Gastroenteritis viral	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Haemophilus infection	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Hepatitis B	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Herpes simplex otitis externa	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Herpes zoster	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Influenza	1.1% 2/188 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.5% 3/194 • Number of events 4 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Listeria sepsis	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Localised infection	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Meningitis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Moraxella infection	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Neutropenic sepsis	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Peritoneal tuberculosis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Pharyngitis	1.1% 2/188 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Pneumococcal bacteraemia	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Pneumocystis jirovecii pneumonia	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Pneumonia	8.0% 15/188 • Number of events 17 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	9.8% 19/194 • Number of events 23 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	12.0% 3/25 • Number of events 4 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Pneumonia influenzal	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Pneumonia legionella	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Pneumonia streptococcal	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Respiratory tract infection	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.0% 2/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Respiratory tract infection fungal	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Respiratory tract infection viral	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Rhinovirus infection	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Scedosporium infection	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Sepsis	2.1% 4/188 • Number of events 4 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Septic shock	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Sinusitis	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.0% 2/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Staphylococcal infection	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Tooth abscess	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Upper respiratory tract infection	1.1% 2/188 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	2.1% 4/194 • Number of events 4 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Urinary tract infection	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Urinary tract infection pseudomonal	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Urosepsis	0.53% 1/188 • Number of events 3 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Varicella zoster virus infection	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Viral infection	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Viral upper respiratory tract infection	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Injury, poisoning and procedural complications Humerus fracture	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Injury, poisoning and procedural complications Infusion related reaction	3.2% 6/188 • Number of events 8 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Injury, poisoning and procedural complications Tendon rupture	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Investigations Body temperature increased	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Metabolism and nutrition disorders Dehydration	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.0% 2/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.0% 2/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.0% 2/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Metabolism and nutrition disorders Tumour lysis syndrome	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	2.1% 4/194 • Number of events 4 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Acute myeloid leukaemia	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma gastric	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.0% 2/194 • Number of events 3 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colon cancer	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal cancer	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.0% 2/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lung neoplasm malignant	1.6% 3/188 • Number of events 3 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Lymphoma	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant melanoma	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.0% 2/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Medullary thyroid cancer	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastatic malignant melanoma	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.0% 2/194 • Number of events 3 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Myelodysplastic syndrome	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.0% 2/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostatic adenoma	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Transitional cell carcinoma	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Nervous system disorders Dizziness	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Nervous system disorders Haemorrhagic stroke	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Nervous system disorders Lacunar infarction	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Nervous system disorders Polyneuropathy	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Nervous system disorders Status epilepticus	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Nervous system disorders Syncope	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Renal and urinary disorders Acute kidney injury	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Renal and urinary disorders Nephrolithiasis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Renal and urinary disorders Renal impairment	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Reproductive system and breast disorders Cervical dysplasia	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Reproductive system and breast disorders Uterine haemorrhage	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Acute respiratory failure	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Bronchiectasis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Skin and subcutaneous tissue disorders Dermatitis allergic	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Vascular disorders Aortic stenosis	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Vascular disorders Deep vein thrombosis	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Vascular disorders Hypotension	2.7% 5/188 • Number of events 5 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Lower respiratory tract infection	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Parainfluenzae virus infection	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Blood and lymphatic system disorders Immune thrombocytopenia	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Cardiac disorders Cardiac failure congestive	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Cardiac disorders Pericarditis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Cardiac disorders Tachycardia	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
General disorders Asthenia	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
General disorders Hyperpyrexia	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
General disorders Malaise	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
General disorders Pyrexia	6.9% 13/188 • Number of events 15 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	2.6% 5/194 • Number of events 5 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
General disorders Sudden cardiac death	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
General disorders Sudden death	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Hepatobiliary disorders Biliary obstruction	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Hepatobiliary disorders Cholecystitis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Hepatobiliary disorders Jaundice cholestatic	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Atypical mycobacterial infection	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations COVID-19	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Gastroenteritis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Pneumonia pseudomonal	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Injury, poisoning and procedural complications Scar	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Injury, poisoning and procedural complications Ulna fracture	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Investigations Electrocardiogram QT prolonged	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Investigations Medical observation	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Investigations SARS-CoV-2 test positive	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Metabolism and nutrition disorders Hypervolaemia	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Colorectal adenocarcinoma	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastases to lung	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Metastasis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Plasma cell myeloma	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sebaceous adenoma	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Skin squamous cell carcinoma recurrent	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of lung	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	1.5% 3/194 • Number of events 7 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Renal and urinary disorders Chronic kidney disease	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Renal and urinary disorders Ureterolithiasis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Skin and subcutaneous tissue disorders Actinic keratosis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Skin and subcutaneous tissue disorders Diabetic foot	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Vascular disorders Haematoma	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Vascular disorders Thrombosis	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.

Other adverse events

Measure	Bendamustine + Rituximab Main Study n=188 participants at risk Participants received bendamustine at a dose of 70 mg/m\^2 via IV infusion on Days 1 and 2 of each 28-day cycle for 6 cycles, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Venetoclax + Rituximab Main Study n=194 participants at risk Participants were initially placed on a venetoclax ramp-up period of 5 weeks, and received an initial dose of 20 mg via tablet orally QD for initial 1 to 7 days, then venetoclax dose was incremented weekly up to a maximum dose of 400 mg via tablet orally QD. Participants continued receiving venetoclax at a dose of 400 mg via tablet orally QD from Week 6 (Day 1 of Cycle 1 of combination therapy) onwards up to PD or 2 years, whichever occurred first, as directed by the investigator, in combination with rituximab at a dose of 375 mg/m\^2 via IV infusion on Day 1 of Cycle 1 and at a dose of 500 mg/m\^2 on Day 1 of Cycles 2-6.	Bendamustine + Rituximab Crossover Substudy n=9 participants at risk Participants who entered the crossover substudy had a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, participants received 6 cycles of rituximab, 375 mg/m\^2, as IV infusion on the Day 1 of each 28-day cycle. Participants who did not progress following the completion of the 6 cycles continued to receive venetoclax monotherapy until disease progression or for a maximum of 2 years from Cycle 1 crossover Day 1 of the substudy.	Venetoclax + Rituximab Re-Treatment Substudy n=25 participants at risk Participants who entered the re-treatment substudy had a 5-week venetoclax dose ramp-up period to reach the target dose of 400 mg QD. Following the venetoclax ramp-up period, participants received 6 cycles of rituximab consisting of a single infusion on the first day of each 28-day cycle. Participants who did not progress following the completion of the 6 cycles continued to receive venetoclax monotherapy until disease progression or for a maximum of 2 year from Cycle 1 re-treatment Day 1 of the substudy.
Blood and lymphatic system disorders Anaemia	21.3% 40/188 • Number of events 68 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	14.4% 28/194 • Number of events 48 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Blood and lymphatic system disorders Neutropenia	44.7% 84/188 • Number of events 182 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	61.9% 120/194 • Number of events 290 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	33.3% 3/9 • Number of events 5 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	20.0% 5/25 • Number of events 13 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Blood and lymphatic system disorders Thrombocytopenia	22.3% 42/188 • Number of events 57 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.9% 23/194 • Number of events 30 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	8.0% 2/25 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Abdominal pain	3.2% 6/188 • Number of events 7 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	6.7% 13/194 • Number of events 14 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Constipation	20.7% 39/188 • Number of events 47 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	13.9% 27/194 • Number of events 31 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Diarrhoea	16.5% 31/188 • Number of events 43 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	40.2% 78/194 • Number of events 120 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	12.0% 3/25 • Number of events 4 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Nausea	34.0% 64/188 • Number of events 82 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	21.6% 42/194 • Number of events 58 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Gastrointestinal disorders Vomiting	11.7% 22/188 • Number of events 29 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	7.7% 15/194 • Number of events 18 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Bronchitis	6.9% 13/188 • Number of events 14 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	10.3% 20/194 • Number of events 32 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Conjunctivitis	2.7% 5/188 • Number of events 5 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	5.2% 10/194 • Number of events 11 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Lower respiratory tract infection	2.1% 4/188 • Number of events 4 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	5.7% 11/194 • Number of events 15 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Nasopharyngitis	5.9% 11/188 • Number of events 15 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.3% 22/194 • Number of events 29 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Oral herpes	6.4% 12/188 • Number of events 12 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.1% 8/194 • Number of events 11 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Pharyngitis	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	7.2% 14/194 • Number of events 17 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Sinusitis	2.7% 5/188 • Number of events 5 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	9.8% 19/194 • Number of events 26 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Upper respiratory tract infection	14.9% 28/188 • Number of events 42 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	23.2% 45/194 • Number of events 81 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Infections and infestations Urinary tract infection	3.7% 7/188 • Number of events 9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	6.2% 12/194 • Number of events 22 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Injury, poisoning and procedural complications Infusion related reaction	21.3% 40/188 • Number of events 54 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	8.2% 16/194 • Number of events 21 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Investigations Alanine aminotransferase increased	5.3% 10/188 • Number of events 11 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	5.2% 10/194 • Number of events 17 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Investigations Neutrophil count decreased	6.9% 13/188 • Number of events 27 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	5.7% 11/194 • Number of events 27 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Metabolism and nutrition disorders Decreased appetite	9.0% 17/188 • Number of events 18 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.1% 8/194 • Number of events 11 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Metabolism and nutrition disorders Hyperkalaemia	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	5.7% 11/194 • Number of events 16 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Metabolism and nutrition disorders Hypokalaemia	3.7% 7/188 • Number of events 7 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	5.7% 11/194 • Number of events 12 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Musculoskeletal and connective tissue disorders Arthralgia	5.9% 11/188 • Number of events 15 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	8.8% 17/194 • Number of events 22 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Musculoskeletal and connective tissue disorders Back pain	5.9% 11/188 • Number of events 11 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	7.2% 14/194 • Number of events 14 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Musculoskeletal and connective tissue disorders Muscle spasms	5.9% 11/188 • Number of events 11 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	2.1% 4/194 • Number of events 4 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Nervous system disorders Dizziness	5.9% 11/188 • Number of events 14 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	6.2% 12/194 • Number of events 14 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Nervous system disorders Headache	10.1% 19/188 • Number of events 21 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	10.8% 21/194 • Number of events 21 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Psychiatric disorders Insomnia	6.4% 12/188 • Number of events 13 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	10.8% 21/194 • Number of events 22 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Cough	16.5% 31/188 • Number of events 37 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	18.6% 36/194 • Number of events 51 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Dyspnoea	7.4% 14/188 • Number of events 17 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	5.7% 11/194 • Number of events 14 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.7% 7/188 • Number of events 7 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	5.2% 10/194 • Number of events 12 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Respiratory, thoracic and mediastinal disorders Productive cough	2.1% 4/188 • Number of events 5 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	6.2% 12/194 • Number of events 14 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Skin and subcutaneous tissue disorders Pruritus	4.8% 9/188 • Number of events 9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	5.2% 10/194 • Number of events 11 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Skin and subcutaneous tissue disorders Rash	13.3% 25/188 • Number of events 29 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	7.7% 15/194 • Number of events 19 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Vascular disorders Hypertension	3.7% 7/188 • Number of events 7 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	7.7% 15/194 • Number of events 15 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Blood and lymphatic system disorders Febrile neutropenia	1.6% 3/188 • Number of events 3 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Cardiac disorders Supraventricular tachycardia	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/194 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
General disorders Chills	8.5% 16/188 • Number of events 20 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.1% 8/194 • Number of events 10 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
General disorders Fatigue	20.7% 39/188 • Number of events 44 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	18.0% 35/194 • Number of events 41 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	4.0% 1/25 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
General disorders Oedema peripheral	3.7% 7/188 • Number of events 11 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	5.2% 10/194 • Number of events 14 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
General disorders Pyrexia	17.6% 33/188 • Number of events 44 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	13.9% 27/194 • Number of events 41 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/9 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Investigations Blood creatinine increased	0.53% 1/188 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	2.6% 5/194 • Number of events 6 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 2 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Investigations White blood cell count decreased	1.6% 3/188 • Number of events 4 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.52% 1/194 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.
Skin and subcutaneous tissue disorders Dermatitis	0.00% 0/188 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	2.6% 5/194 • Number of events 5 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	11.1% 1/9 • Number of events 1 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.	0.00% 0/25 • From signing of informed consent form up to approximately 8 years 5 months SE population included all randomized participants who received at least one dose of study treatment with participants grouped according to the actual treatment received.

Additional Information

Medical Communications

Hoffmann-La Roche

Phone: 800-821-8590

Email: genentech@druginfo.com

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