Trial Outcomes & Findings for A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy (NCT NCT02755597)

NCT ID: NCT02755597

Last Updated: 2023-08-22

Results Overview

PFS is defined as the number of days from the date the participant was randomized to the date of the first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 291 participants
• Primary outcome timeframe: Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group
• Results posted on: 2023-08-22

Participant Flow

Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization

Participant milestones

Measure	Venetoclax + Bortezomib and Dexamethasone Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Overall Study STARTED	194	97
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	194	97

Reasons for withdrawal

Measure	Venetoclax + Bortezomib and Dexamethasone Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Overall Study Withdrew consent	27	11
Overall Study Lost to Follow-up	1	0
Overall Study Death	78	36
Overall Study Study terminated by Sponsor	67	47
Overall Study Other, not specified	20	3
Overall Study Participant missing reason for study discontinuation	1	0

Baseline Characteristics

A Study Evaluating Venetoclax (ABT-199) in Multiple Myeloma Subjects Who Are Receiving Bortezomib and Dexamethasone as Standard Therapy

Baseline characteristics by cohort

Measure	Venetoclax + Bortezomib and Dexamethasone n=194 Participants Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=97 Participants Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23	Total n=291 Participants Total of all reporting groups
Age, Continuous	65.9 years STANDARD_DEVIATION 9.41 • n=5 Participants	65.9 years STANDARD_DEVIATION 7.81 • n=7 Participants	65.9 years STANDARD_DEVIATION 8.90 • n=5 Participants
Sex: Female, Male Female	97 Participants n=5 Participants	42 Participants n=7 Participants	139 Participants n=5 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	55 Participants n=7 Participants	152 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	25 Participants n=5 Participants	7 Participants n=7 Participants	32 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	169 Participants n=5 Participants	90 Participants n=7 Participants	259 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	59 Participants n=5 Participants	28 Participants n=7 Participants	87 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	9 Participants n=5 Participants	3 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) White	124 Participants n=5 Participants	66 Participants n=7 Participants	190 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Time since diagnosis	1263.5 days n=5 Participants	1461.0 days n=7 Participants	1318.0 days n=5 Participants
Number of prior lines of therapy	1.0 number of prior lines of therapy n=5 Participants	2.0 number of prior lines of therapy n=7 Participants	1.0 number of prior lines of therapy n=5 Participants
Number of prior lines of multiple myeloma therapy 1 line	91 Participants n=5 Participants	44 Participants n=7 Participants	135 Participants n=5 Participants
Number of prior lines of multiple myeloma therapy 2-3 lines	103 Participants n=5 Participants	53 Participants n=7 Participants	156 Participants n=5 Participants
Prior exposure to proteasome inhibitors (PI) Refractory	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Prior exposure to proteasome inhibitors (PI) Sensitive	131 Participants n=5 Participants	66 Participants n=7 Participants	197 Participants n=5 Participants
Prior exposure to proteasome inhibitors (PI) Naïve	61 Participants n=5 Participants	28 Participants n=7 Participants	89 Participants n=5 Participants
Prior exposure to proteasome inhibitors (PI) Unknown	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Prior exposure to proteasome inhibitors (PI) MISSING	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Prior exposure to an immunomodulatory drug (IMID) Refractory	64 Participants n=5 Participants	36 Participants n=7 Participants	100 Participants n=5 Participants
Prior exposure to an immunomodulatory drug (IMID) Sensitive	67 Participants n=5 Participants	29 Participants n=7 Participants	96 Participants n=5 Participants
Prior exposure to an immunomodulatory drug (IMID) Naïve	63 Participants n=5 Participants	30 Participants n=7 Participants	93 Participants n=5 Participants
Prior exposure to an immunomodulatory drug (IMID) Unknown	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Prior exposure to an immunomodulatory drug (IMID) MISSING	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Prior exposure to an anti-CD38 monoclonal antibody Refractory	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Prior exposure to an anti-CD38 monoclonal antibody Sensitive	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Prior exposure to an anti-CD38 monoclonal antibody Naïve	185 Participants n=5 Participants	95 Participants n=7 Participants	280 Participants n=5 Participants
Prior exposure to an anti-CD38 monoclonal antibody Unknown	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Prior exposure to an anti-CD38 monoclonal antibody MISSING	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Multiple myeloma International Staging System(ISS) stage Stage I	81 Participants n=5 Participants	48 Participants n=7 Participants	129 Participants n=5 Participants
Multiple myeloma International Staging System(ISS) stage Stage II	69 Participants n=5 Participants	32 Participants n=7 Participants	101 Participants n=5 Participants
Multiple myeloma International Staging System(ISS) stage Stage III	39 Participants n=5 Participants	13 Participants n=7 Participants	52 Participants n=5 Participants
Multiple myeloma International Staging System(ISS) stage Not evaluable	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Multiple myeloma International Staging System(ISS) stage MISSING	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Chromosomal abnormality (CA) risk by fluorescent in situ hybridization (FISH) High	31 Participants n=5 Participants	18 Participants n=7 Participants	49 Participants n=5 Participants
Chromosomal abnormality (CA) risk by fluorescent in situ hybridization (FISH) Standard	141 Participants n=5 Participants	72 Participants n=7 Participants	213 Participants n=5 Participants
Chromosomal abnormality (CA) risk by fluorescent in situ hybridization (FISH) Unknown	9 Participants n=5 Participants	4 Participants n=7 Participants	13 Participants n=5 Participants
Chromosomal abnormality (CA) risk by fluorescent in situ hybridization (FISH) MISSING	13 Participants n=5 Participants	3 Participants n=7 Participants	16 Participants n=5 Participants
Prior stem cell transplant Autologous	114 Participants n=5 Participants	57 Participants n=7 Participants	171 Participants n=5 Participants
Prior stem cell transplant Allogeneic	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Prior stem cell transplant Syngeneic	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Prior stem cell transplant MISSING	78 Participants n=5 Participants	40 Participants n=7 Participants	118 Participants n=5 Participants

PRIMARY outcome

Timeframe: Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

Population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization

PFS is defined as the number of days from the date the participant was randomized to the date of the first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology.

Outcome measures

Measure	Venetoclax + Bortezomib and Dexamethasone n=194 Participants Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=97 Participants Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Progression-free Survival (PFS)	23.2 months Interval 15.3 to 27.5	11.5 months Interval 9.6 to 15.0

SECONDARY outcome

Timeframe: Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

Population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization

The percentage of participants with documented best overall response of Very Good Partial Response (VGPR) or better (VGPR, Complete response [CR], or Stringent complete response [sCR]) per 2016 standard International Myeloma Working Group (IMWG) criteria as determined by an Independent Review Committee (IRC) was computed.

Outcome measures

Measure	Venetoclax + Bortezomib and Dexamethasone n=194 Participants Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=97 Participants Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Very Good Partial Response (VGPR) or Better Response Rate	60.3 percentage of participants Interval 53.1 to 67.2	38.1 percentage of participants Interval 28.5 to 48.6

SECONDARY outcome

Timeframe: Median duration of follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

Population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization who had high BCL-2 expression

PFS is defined as the number of days from the date the participant was randomized to the date of the first documented progressive disease (PD) per investigator assessment or death due to any cause, whichever occurs first. PFS was analyzed by Kaplan-Meier methodology.

BCL-2 expression was determined through central laboratory testing by immunohistochemistry (IHC) and based on a pre-specified scoring algorithm. High clinical score of 2+: ≥50% of tumor cells with moderate or higher cytoplasmic staining but < 50% of tumor cells with strong staining intensity; high clinical score of 3+: ≥50% of tumor cells with strong cytoplasmic staining.

Outcome measures

Measure	Venetoclax + Bortezomib and Dexamethasone n=93 Participants Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=47 Participants Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Progression-Free Survival (PFS) in Participants With High B-cell Lymphoma 2 (BCL-2) Expression	23.8 months Interval 19.5 to 34.7	11.4 months Interval 9.1 to 15.0

SECONDARY outcome

Timeframe: Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

Population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization

DOR is defined as the number of days from the participant's date of first documented response (partial response [PR] or better) to the date of first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to multiple myeloma, whichever occurs first. DOR was analyzed by Kaplan-Meier methodology.

Outcome measures

Measure	Venetoclax + Bortezomib and Dexamethasone n=158 Participants Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=67 Participants Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Duration of Response (DOR)	NA months Interval 22.8 to Not estimable/calculable due to low number of participants with events	12.8 months Interval 10.6 to 15.5

SECONDARY outcome

Timeframe: Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment

Population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization; participants who have both baseline and post-baseline values are included in the analysis at each visit

The BPI-SF is a pain-specific measure developed to assess patient-reported severity (or intensity) of pain (4 items) and the impact of pain on daily functioning (7 items) in patients with cancer pain. The four pain severity items assess pain at its "worst in last 24 hours," "least in last 24 hours," "average," and "now" (current pain). For these items, participants are asked to rate their pain on an 11-point numeric rating scale with anchors of 0 (no pain) and 10 (pain as bad as you can imagine). The Worst Pain scores range from 0 to 10, with higher scores indicating severe pain. Negative changes from baseline indicate improvement.

Outcome measures

Measure	Venetoclax + Bortezomib and Dexamethasone n=184 Participants Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=92 Participants Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 7, Day 1	-0.1 units on a scale Standard Deviation 2.56	0.2 units on a scale Standard Deviation 2.98
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 11, Day 1	-0.4 units on a scale Standard Deviation 2.57	0.1 units on a scale Standard Deviation 3.45
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 13, Day 1	-0.2 units on a scale Standard Deviation 2.71	-0.1 units on a scale Standard Deviation 3.22
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 15, Day 1	-0.2 units on a scale Standard Deviation 2.92	-0.0 units on a scale Standard Deviation 3.08
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 21, Day 1	-0.1 units on a scale Standard Deviation 2.39	-0.3 units on a scale Standard Deviation 2.89
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 29, Day 1	-0.2 units on a scale Standard Deviation 2.83	0.3 units on a scale Standard Deviation 2.15
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 33, Day 1	-0.2 units on a scale Standard Deviation 2.88	0.4 units on a scale Standard Deviation 1.40
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 35, Day 1	0.1 units on a scale Standard Deviation 2.77	-0.2 units on a scale Standard Deviation 1.33
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 37, Day 1	0.4 units on a scale Standard Deviation 2.78	1.5 units on a scale Standard Deviation 2.65
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 39, Day 1	0.1 units on a scale Standard Deviation 2.70	-0.3 units on a scale Standard Deviation 1.15
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 41, Day 1	0.1 units on a scale Standard Deviation 3.00	0.3 units on a scale Standard Deviation 1.15
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 43, Day 1	-0.1 units on a scale Standard Deviation 3.07	0.5 units on a scale Standard Deviation 0.71
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 45, Day 1	-0.7 units on a scale Standard Deviation 3.64	1.0 units on a scale Standard Deviation 0.00
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 47, Day 1	-2.8 units on a scale Standard Deviation 3.77	1.0 units on a scale
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Final visit	0.3 units on a scale Standard Deviation 3.28	0.4 units on a scale Standard Deviation 3.55
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 3, Day 1	-0.6 units on a scale Standard Deviation 2.59	-0.5 units on a scale Standard Deviation 2.46
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 5, Day 1	0.0 units on a scale Standard Deviation 2.65	-0.2 units on a scale Standard Deviation 3.15
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 9, Day 1	-0.2 units on a scale Standard Deviation 3.11	0.0 units on a scale Standard Deviation 2.88
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 17, Day 1	-0.3 units on a scale Standard Deviation 2.54	-0.1 units on a scale Standard Deviation 2.06
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 19, Day 1	-0.1 units on a scale Standard Deviation 2.59	-0.2 units on a scale Standard Deviation 1.95
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 23, Day 1	-0.0 units on a scale Standard Deviation 3.20	-0.2 units on a scale Standard Deviation 2.61
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 25, Day 1	0.4 units on a scale Standard Deviation 2.65	0.2 units on a scale Standard Deviation 3.00
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 27, Day 1	0.2 units on a scale Standard Deviation 2.53	0.1 units on a scale Standard Deviation 1.92
Mean Change From Baseline in Brief Pain Inventory - Short Form (BPI-SF) Worst Pain Cycle 31, Day 1	0.0 units on a scale Standard Deviation 3.11	0.6 units on a scale Standard Deviation 1.33

SECONDARY outcome

Timeframe: Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment

Population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization; participants who have both baseline and post-baseline values are included in the analysis at each visit

The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Physical Functioning scale, participants rate five items on a four-point scale, with 1 as "not at all" and 4 as "very much." The Physical Functioning Scale scores range from 0 to 100 and were calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high scale score represents high/healthy level of functioning. Positive changes from baseline indicate improvement.

Outcome measures

Measure	Venetoclax + Bortezomib and Dexamethasone n=184 Participants Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=92 Participants Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1	-5.0 units on a scale Standard Deviation 18.22	-4.6 units on a scale Standard Deviation 19.50
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 5, Day 1	-3.9 units on a scale Standard Deviation 18.38	-7.8 units on a scale Standard Deviation 21.50
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 7, Day 1	-6.1 units on a scale Standard Deviation 20.19	-8.6 units on a scale Standard Deviation 19.76
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 9, Day 1	-3.5 units on a scale Standard Deviation 19.54	-8.0 units on a scale Standard Deviation 20.01
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 11, Day 1	-1.5 units on a scale Standard Deviation 15.92	-7.5 units on a scale Standard Deviation 18.46
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 15, Day 1	-2.3 units on a scale Standard Deviation 18.72	-7.3 units on a scale Standard Deviation 22.27
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 17, Day 1	-1.8 units on a scale Standard Deviation 16.23	-8.6 units on a scale Standard Deviation 19.90
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 21, Day 1	-1.5 units on a scale Standard Deviation 17.81	-8.5 units on a scale Standard Deviation 20.43
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 23, Day 1	-3.4 units on a scale Standard Deviation 20.32	-7.5 units on a scale Standard Deviation 20.53
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 29, Day 1	-8.7 units on a scale Standard Deviation 21.25	-4.0 units on a scale Standard Deviation 19.81
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 31, Day 1	-2.8 units on a scale Standard Deviation 17.98	2.2 units on a scale Standard Deviation 18.56
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 33, Day 1	-4.0 units on a scale Standard Deviation 22.76	-4.8 units on a scale Standard Deviation 23.64
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 39, Day 1	-10.1 units on a scale Standard Deviation 18.80	8.9 units on a scale Standard Deviation 10.18
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 41, Day 1	-13.0 units on a scale Standard Deviation 25.65	13.3 units on a scale Standard Deviation 23.09
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 45, Day 1	-1.3 units on a scale Standard Deviation 10.33	13.3 units on a scale Standard Deviation 18.86
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 47, Day 1	0.0 units on a scale Standard Deviation 14.40	0.0 units on a scale
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Final visit	-11.8 units on a scale Standard Deviation 22.85	-10.0 units on a scale Standard Deviation 21.52
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 13, Day 1	-3.2 units on a scale Standard Deviation 16.57	-8.8 units on a scale Standard Deviation 22.85
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 19, Day 1	-2.5 units on a scale Standard Deviation 19.30	-7.0 units on a scale Standard Deviation 19.35
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 25, Day 1	-3.8 units on a scale Standard Deviation 17.28	0.5 units on a scale Standard Deviation 23.95
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 27, Day 1	-8.6 units on a scale Standard Deviation 21.69	-3.3 units on a scale Standard Deviation 18.44
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 35, Day 1	-7.0 units on a scale Standard Deviation 16.64	4.4 units on a scale Standard Deviation 18.70
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 37, Day 1	-7.5 units on a scale Standard Deviation 22.49	15.0 units on a scale Standard Deviation 14.78
Mean Change From Baseline in Physical Functioning Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 43, Day 1	-7.8 units on a scale Standard Deviation 23.12	13.3 units on a scale Standard Deviation 18.86

SECONDARY outcome

Timeframe: Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment

Population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization; participants who have both baseline and post-baseline values are included in the analysis at each visit

The QLQ-C30 is a 30-item subject self-report questionnaire composed of both multi-item and single scales, including five functional scales (physical, role, emotional, social, and cognitive), three symptom scales (fatigue, nausea and vomiting, and pain), a global health status/quality of life scale, and six single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). For the Global Health Status/Quality of Life scale, participants rate two items on a seven point scale, with 1 as "very poor" and 7 as "excellent." The Global Health Status/Quality of Life scale ranges from 0 to 100 and was calculated per the EORTC QLQ-C30 Scoring Manual (3rd edition), version 3.0. A high score for the global health status/QoL represents a high QoL. Positive changes from baseline indicate improvement.

Outcome measures

Measure	Venetoclax + Bortezomib and Dexamethasone n=184 Participants Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=92 Participants Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 19, Day 1	-1.3 units on a scale Standard Deviation 19.51	0.8 units on a scale Standard Deviation 26.09
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 21, Day 1	-6.6 units on a scale Standard Deviation 26.16	-5.6 units on a scale Standard Deviation 20.01
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 23, Day 1	-2.9 units on a scale Standard Deviation 23.20	-1.0 units on a scale Standard Deviation 22.99
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 25, Day 1	-4.7 units on a scale Standard Deviation 26.29	-4.5 units on a scale Standard Deviation 24.68
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 27, Day 1	-9.0 units on a scale Standard Deviation 24.46	4.2 units on a scale Standard Deviation 26.70
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 29, Day 1	-6.9 units on a scale Standard Deviation 24.67	-1.1 units on a scale Standard Deviation 26.33
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 31, Day 1	-4.8 units on a scale Standard Deviation 26.48	5.6 units on a scale Standard Deviation 35.36
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 33, Day 1	-7.7 units on a scale Standard Deviation 27.22	-7.1 units on a scale Standard Deviation 22.79
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 35, Day 1	-3.8 units on a scale Standard Deviation 24.03	4.2 units on a scale Standard Deviation 29.23
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 37, Day 1	-13.7 units on a scale Standard Deviation 29.86	10.4 units on a scale Standard Deviation 12.50
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 39, Day 1	-9.3 units on a scale Standard Deviation 28.05	0.0 units on a scale Standard Deviation 0.00
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 47, Day 1	10.4 units on a scale Standard Deviation 22.95	-8.3 units on a scale
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Final visit	-8.1 units on a scale Standard Deviation 26.40	-6.7 units on a scale Standard Deviation 28.50
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 41, Day 1	-11.0 units on a scale Standard Deviation 30.47	8.3 units on a scale Standard Deviation 8.33
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 43, Day 1	2.0 units on a scale Standard Deviation 28.95	-8.3 units on a scale Standard Deviation 23.57
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 45, Day 1	-1.7 units on a scale Standard Deviation 33.75	4.2 units on a scale Standard Deviation 5.89
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 3, Day 1	-1.9 units on a scale Standard Deviation 22.75	-2.2 units on a scale Standard Deviation 22.63
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 5, Day 1	-5.1 units on a scale Standard Deviation 26.74	-2.5 units on a scale Standard Deviation 23.54
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 7, Day 1	-8.3 units on a scale Standard Deviation 26.76	-6.7 units on a scale Standard Deviation 24.56
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 11, Day 1	-0.5 units on a scale Standard Deviation 25.58	-5.2 units on a scale Standard Deviation 25.38
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 17, Day 1	-5.1 units on a scale Standard Deviation 24.91	-7.7 units on a scale Standard Deviation 21.55
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 9, Day 1	-6.9 units on a scale Standard Deviation 26.33	-6.7 units on a scale Standard Deviation 24.22
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 13, Day 1	-1.0 units on a scale Standard Deviation 25.05	-1.7 units on a scale Standard Deviation 22.24
Mean Change From Baseline in Global Health Status/Quality of Life Scale of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Cycle 15, Day 1	-4.9 units on a scale Standard Deviation 26.09	0.5 units on a scale Standard Deviation 23.56

SECONDARY outcome

Timeframe: Baseline; Cycle 3 (Cycles 1 - 8 are 21 days, Cycles 9 and beyond are 35 days) through Cycle 47, collected on Day 1 of every other cycle and at the Treatment Completion Visit (TCV) while participant is on treatment

Population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization; participants who have both baseline and post-baseline values are included in the analysis at each visit

PROMIS Cancer Fatigue SF is a seven item questionnaire that assesses the impact and experience of fatigue over the past 7 days. All questions employ the following five response options: 1 = Not at all, 2 = A little bit, 3 = Somewhat, 4 = Quite a bit, and 5 = Very much. The total raw score is the sum of the responses to each question and is converted to a T-score. The T-score re-scales the total raw score to a standardized score with a mean of 50 and a standard deviation of 10. The [PROMIS] Cancer Fatigue Short Form [SF] 7a T-Scores range from 29.4 to 83.2, with higher scores indicating more fatigue. Negative changes from baseline indicate improvement.

Outcome measures

Measure	Venetoclax + Bortezomib and Dexamethasone n=185 Participants Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=92 Participants Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 5, Day 1	3.3 T-score Standard Deviation 9.25	2.4 T-score Standard Deviation 10.34
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 45, Day 1	-0.3 T-score Standard Deviation 7.99	1.8 T-score Standard Deviation 0.28
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 3, Day 1	2.2 T-score Standard Deviation 9.54	1.8 T-score Standard Deviation 8.12
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 7, Day 1	3.2 T-score Standard Deviation 9.28	2.6 T-score Standard Deviation 9.70
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 9, Day 1	2.3 T-score Standard Deviation 8.90	2.6 T-score Standard Deviation 8.67
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 11, Day 1	0.6 T-score Standard Deviation 8.54	3.1 T-score Standard Deviation 8.98
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 13, Day 1	1.8 T-score Standard Deviation 8.03	2.3 T-score Standard Deviation 6.97
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 15, Day 1	1.5 T-score Standard Deviation 8.84	2.1 T-score Standard Deviation 7.66
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 17, Day 1	1.2 T-score Standard Deviation 8.11	2.6 T-score Standard Deviation 8.05
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 19, Day 1	0.7 T-score Standard Deviation 8.52	0.9 T-score Standard Deviation 9.32
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 21, Day 1	1.6 T-score Standard Deviation 8.58	1.2 T-score Standard Deviation 7.66
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 23, Day 1	2.0 T-score Standard Deviation 8.08	1.5 T-score Standard Deviation 8.83
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 25, Day 1	2.0 T-score Standard Deviation 8.59	-0.1 T-score Standard Deviation 8.73
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 27, Day 1	3.4 T-score Standard Deviation 8.19	-0.1 T-score Standard Deviation 9.59
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 29, Day 1	3.9 T-score Standard Deviation 8.07	0.8 T-score Standard Deviation 8.51
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 31, Day 1	2.8 T-score Standard Deviation 8.43	-0.3 T-score Standard Deviation 9.15
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 33, Day 1	2.0 T-score Standard Deviation 8.93	3.7 T-score Standard Deviation 9.17
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 35, Day 1	3.4 T-score Standard Deviation 9.27	1.1 T-score Standard Deviation 7.22
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 37, Day 1	4.1 T-score Standard Deviation 9.72	-3.0 T-score Standard Deviation 11.72
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 39, Day 1	3.6 T-score Standard Deviation 8.12	4.1 T-score Standard Deviation 2.82
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 41, Day 1	3.3 T-score Standard Deviation 8.69	-0.7 T-score Standard Deviation 6.90
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 43, Day 1	5.3 T-score Standard Deviation 9.28	4.4 T-score Standard Deviation 1.91
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Cycle 47, Day 1	-2.5 T-score Standard Deviation 6.30	0.0 T-score
Mean Change From Baseline in Patient Reported Outcomes Measurement Information System [PROMIS] Cancer Fatigue Short Form [SF] Score Final visit	5.0 T-score Standard Deviation 10.95	2.9 T-score Standard Deviation 9.96

SECONDARY outcome

Timeframe: Median duration of follow-up was 45.6 months for the venetoclax group and 45.6 months for the placebo group

Population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization

OS is defined as the number of days from the date of randomization to the date of death due to any cause. All events of death were to be included, regardless of whether the event occurred while the participant was still taking study drug or after the participant discontinued study drug. If a participant is not known to have died, OS was censored at the date of last contact. The distribution of OS was estimated using Kaplan-Meier methodology.

Outcome measures

Measure	Venetoclax + Bortezomib and Dexamethasone n=194 Participants Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=97 Participants Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Overall Survival (OS).	NA months Interval 44.4 to Not estimable/calculable due to low number of participants with events	NA months Interval 44.0 to Not estimable/calculable due to low number of participants with events

SECONDARY outcome

Timeframe: Median time on follow-up up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

Population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization

TTP is defined as the number of days from the date of randomization to the date of first documented progressive disease (PD) as determined by an Independent Review Committee (IRC) or death due to multiple myeloma, whichever occurs first. TTP was analyzed by Kaplan-Meier methodology.

Outcome measures

Measure	Venetoclax + Bortezomib and Dexamethasone n=194 Participants Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=97 Participants Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Time to Progression (TTP)	25.4 months Interval 20.6 to Not estimable/calculable due to low number of participants with events	12.2 months Interval 9.9 to 15.0

SECONDARY outcome

Timeframe: Response was assessed at Cycle 1, Day 1, and on Day 1 of every cycle thereafter; median time on follow-up was 28.6 months for the venetoclax group and 28.6 months for the placebo group

Population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization

Overall response rate is defined as the percentage of participants with documented best overall response of Partial Response (PR) or better (PR, Very good partial response [VGPR], Complete response [CR], or Stringent complete response [sCR]) per International Myeloma Working Group (IMWG) criteria as determined by an Independent Review Committee (IRC).

Outcome measures

Measure	Venetoclax + Bortezomib and Dexamethasone n=194 Participants Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=97 Participants Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Overall Response Rate (ORR)	81.4 percentage of participants Interval 75.2 to 86.7	69.1 percentage of participants Interval 58.9 to 78.1

SECONDARY outcome

Timeframe: Assessed at Screening; to confirm a stringent Complete Response (sCR) or Complete Response (CR); at 6 months and 12 months post-confirmed CR/sCR

Population: Intent-To-Treat (ITT) analysis set: all randomized participants, analyzed by treatment group assignment given at the time of randomization

MRD negativity rate is defined as the percentage of participants who have negative MRD by bone marrow aspirate at any time point after randomization and before progression or starting subsequent therapy. MRD negativity was defined at 10^-5 threshold (less than one residual myeloma cell per 10^5 total nucleated cells) as measured by centralized testing of bone marrow aspirate by Next Generation Sequencing (NGS). MRD positive participants include those of which all tested samples were found to be MRD positive or indeterminate. Participants with missing or unevaluable MRD status were considered as MRD positive.

Outcome measures

Measure	Venetoclax + Bortezomib and Dexamethasone n=194 Participants Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=97 Participants Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Minimal Residual Disease (MRD) Negativity Rate	15.5 percentage of participants Interval 10.7 to 21.3	2.1 percentage of participants Interval 0.3 to 7.3

Adverse Events

Venetoclax + Bortezomib and Dexamethasone

Serious events: 115 serious events

Other events: 191 other events

Deaths: 81 deaths

Placebo + Bortezomib and Dexamethasone

Serious events: 53 serious events

Other events: 95 other events

Deaths: 36 deaths

Serious adverse events

Measure	Venetoclax + Bortezomib and Dexamethasone n=193 participants at risk Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=96 participants at risk Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Blood and lymphatic system disorders ANAEMIA	2.1% 4/193 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	3.1% 6/193 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Blood and lymphatic system disorders LYMPHOPENIA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Blood and lymphatic system disorders NEUTROPENIA	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Blood and lymphatic system disorders PANCYTOPENIA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Blood and lymphatic system disorders THROMBOCYTOPENIA	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Cardiac disorders ANGINA UNSTABLE	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Cardiac disorders ATRIAL FIBRILLATION	2.1% 4/193 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Cardiac disorders CARDIAC ARREST	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Cardiac disorders CARDIAC FAILURE	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Cardiac disorders CARDIOMYOPATHY	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Cardiac disorders CORONARY ARTERY DISEASE	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Cardiac disorders MYOCARDIAL INFARCTION	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Cardiac disorders TOXIC CARDIOMYOPATHY	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Eye disorders CATARACT	1.6% 3/193 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	3.1% 3/96 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Eye disorders GLAUCOMA	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders ABDOMINAL PAIN	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders COLITIS	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders CONSTIPATION	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders CROHN'S DISEASE	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders DIARRHOEA	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	2.1% 2/96 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders DYSPEPSIA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders ENTEROCOLITIS	0.52% 1/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders GASTRIC ULCER	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders ILEUS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	2.1% 2/96 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders INCARCERATED INGUINAL HERNIA	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders INTESTINAL PSEUDO-OBSTRUCTION	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders LARGE INTESTINE POLYP	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders SMALL INTESTINAL OBSTRUCTION	1.6% 3/193 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders VOMITING	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
General disorders ASTHENIA	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
General disorders DEATH	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
General disorders FATIGUE	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
General disorders MULTIPLE ORGAN DYSFUNCTION SYNDROME	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
General disorders PYREXIA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Hepatobiliary disorders BILIARY COLIC	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Hepatobiliary disorders CHOLECYSTITIS ACUTE	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations ARTHRITIS BACTERIAL	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations ATYPICAL PNEUMONIA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations BILIARY SEPSIS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations BRONCHITIS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations CELLULITIS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations COVID-19	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations COVID-19 PNEUMONIA	3.1% 6/193 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations ENDOCARDITIS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations ERYSIPELAS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations GASTROENTERITIS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations HAEMOPHILUS INFECTION	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations HEPATITIS B REACTIVATION	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations HERPES ZOSTER	1.6% 3/193 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations INFECTION	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations INFECTIVE EXACERBATION OF CHRONIC OBSTRUCTIVE AIRWAYS DISEASE	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations INFLUENZA	1.6% 3/193 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	4.2% 4/96 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations LARGE INTESTINE INFECTION	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations LISTERIOSIS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	2.1% 4/193 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	5.2% 5/96 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations MEDICAL DEVICE SITE INFECTION	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations METAPNEUMOVIRUS INFECTION	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations NECROTISING FASCIITIS	0.52% 1/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations PARAINFLUENZAE VIRUS INFECTION	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations PERIODONTITIS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations PERITONITIS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations PNEUMOCYSTIS JIROVECII PNEUMONIA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations PNEUMONIA	18.1% 35/193 • Number of events 53 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	14.6% 14/96 • Number of events 19 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations PNEUMONIA ADENOVIRAL	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations PNEUMONIA ASPIRATION	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations PNEUMONIA BACTERIAL	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations PNEUMONIA INFLUENZAL	2.1% 4/193 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations PNEUMONIA PNEUMOCOCCAL	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations RESPIRATORY SYNCYTIAL VIRUS INFECTION	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations RESPIRATORY TRACT INFECTION	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations RHINOVIRUS INFECTION	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations SEPSIS	3.1% 6/193 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations SEPTIC SHOCK	0.52% 1/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations STREPTOCOCCAL BACTERAEMIA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations TONSILLITIS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	1.6% 3/193 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations URINARY TRACT INFECTION	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	2.1% 2/96 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications ANKLE FRACTURE	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	2.1% 2/96 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications FALL	1.6% 3/193 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications FEMUR FRACTURE	1.6% 3/193 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	3.1% 3/96 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications FOREARM FRACTURE	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications HIP FRACTURE	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications HUMERUS FRACTURE	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications JOINT DISLOCATION	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications LIGAMENT SPRAIN	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications MULTIPLE FRACTURES	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications PELVIC FRACTURE	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications RADIUS FRACTURE	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications SOFT TISSUE INJURY	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications SPINAL COMPRESSION FRACTURE	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Investigations C-REACTIVE PROTEIN INCREASED	0.52% 1/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Investigations INFLUENZA A VIRUS TEST POSITIVE	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Metabolism and nutrition disorders DEHYDRATION	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Metabolism and nutrition disorders DIABETES MELLITUS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Metabolism and nutrition disorders HYPERVOLAEMIA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Metabolism and nutrition disorders METABOLIC ACIDOSIS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders BACK PAIN	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	2.1% 2/96 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders BONE LESION	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders BONE PAIN	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders CHONDROCALCINOSIS PYROPHOSPHATE	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders HAEMATOMA MUSCLE	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders OSTEONECROSIS OF JAW	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders SACRAL PAIN	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders SPINAL PAIN	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders VERTEBRAL WEDGING	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHOLESTEATOMA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT MEDIASTINAL NEOPLASM	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MALIGNANT NEOPLASM PROGRESSION	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NEUROENDOCRINE TUMOUR	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) NON-SMALL CELL LUNG CANCER METASTATIC	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF LUNG	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) TUMOUR PAIN	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Nervous system disorders AUTONOMIC NEUROPATHY	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Nervous system disorders BRAIN OEDEMA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Nervous system disorders COMA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Nervous system disorders EMBOLIC STROKE	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Nervous system disorders HEADACHE	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Nervous system disorders NEUROPATHY PERIPHERAL	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Nervous system disorders SYNCOPE	2.1% 4/193 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Psychiatric disorders CONFUSIONAL STATE	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Psychiatric disorders SUICIDE ATTEMPT	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Renal and urinary disorders ACUTE KIDNEY INJURY	1.6% 3/193 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	3.1% 3/96 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Renal and urinary disorders POLLAKIURIA	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Renal and urinary disorders RENAL IMPAIRMENT	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Reproductive system and breast disorders ENDOMETRIOSIS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.52% 1/193 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	2.1% 2/96 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	1.6% 3/193 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders HYPOXIA	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders LUNG DISORDER	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.52% 1/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders PULMONARY CONGESTION	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	1.6% 3/193 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders SINUS DISORDER	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Skin and subcutaneous tissue disorders DRUG ERUPTION	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Vascular disorders DEEP VEIN THROMBOSIS	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Vascular disorders EMBOLISM	0.00% 0/193 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Vascular disorders HYPOTENSION	1.0% 2/193 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Vascular disorders ORTHOSTATIC HYPOTENSION	2.6% 5/193 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	2.1% 2/96 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Vascular disorders PERIPHERAL ARTERIAL OCCLUSIVE DISEASE	0.52% 1/193 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.

Other adverse events

Measure	Venetoclax + Bortezomib and Dexamethasone n=193 participants at risk Cycles 1-8: Venetoclax 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Venetoclax 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 and 23	Placebo + Bortezomib and Dexamethasone n=96 participants at risk Cycles 1-8: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 21 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 4, 8 \& 11 and dexamethasone 20 mg orally on Days 1, 2, 4, 5, 8, 9, 11 \& 12; Cycles 9 and beyond: Placebo (to match venetoclax 100 mg tablet) 800 mg orally every day (QD) on Days 1 - 35 plus bortezomib 1.3 mg/m\^2 subcutaneously or IV on Days 1, 8, 15 and 22 and dexamethasone 20 mg orally on Days 1, 2, 8, 9, 15, 16, 22 \& 23
Blood and lymphatic system disorders ANAEMIA	24.9% 48/193 • Number of events 73 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	24.0% 23/96 • Number of events 31 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Blood and lymphatic system disorders LYMPHOPENIA	9.8% 19/193 • Number of events 54 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Blood and lymphatic system disorders NEUTROPENIA	28.0% 54/193 • Number of events 183 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	9.4% 9/96 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Blood and lymphatic system disorders THROMBOCYTOPENIA	27.5% 53/193 • Number of events 120 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	35.4% 34/96 • Number of events 78 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Cardiac disorders PALPITATIONS	2.6% 5/193 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	6.2% 6/96 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Eye disorders CATARACT	12.4% 24/193 • Number of events 33 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	11.5% 11/96 • Number of events 17 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Eye disorders VISION BLURRED	4.1% 8/193 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	5.2% 5/96 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders ABDOMINAL DISCOMFORT	5.2% 10/193 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders ABDOMINAL DISTENSION	7.8% 15/193 • Number of events 17 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	3.1% 3/96 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders ABDOMINAL PAIN	11.9% 23/193 • Number of events 38 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	8.3% 8/96 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	10.4% 20/193 • Number of events 26 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	7.3% 7/96 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders CONSTIPATION	35.2% 68/193 • Number of events 89 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	30.2% 29/96 • Number of events 35 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders DIARRHOEA	59.1% 114/193 • Number of events 282 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	47.9% 46/96 • Number of events 79 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders DYSPEPSIA	12.4% 24/193 • Number of events 28 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	9.4% 9/96 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders FLATULENCE	6.2% 12/193 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	2.1% 2/96 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders GASTRITIS	5.2% 10/193 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	3.1% 3/96 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders NAUSEA	37.8% 73/193 • Number of events 112 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	22.9% 22/96 • Number of events 28 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders STOMATITIS	4.1% 8/193 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	5.2% 5/96 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Gastrointestinal disorders VOMITING	19.7% 38/193 • Number of events 62 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	17.7% 17/96 • Number of events 27 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
General disorders ASTHENIA	15.5% 30/193 • Number of events 39 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	2.1% 2/96 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
General disorders FATIGUE	32.6% 63/193 • Number of events 90 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	32.3% 31/96 • Number of events 43 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
General disorders INFLUENZA LIKE ILLNESS	5.2% 10/193 • Number of events 20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	7.3% 7/96 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
General disorders INJECTION SITE REACTION	2.6% 5/193 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	5.2% 5/96 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
General disorders MALAISE	5.2% 10/193 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	2.1% 2/96 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
General disorders OEDEMA PERIPHERAL	19.7% 38/193 • Number of events 57 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	20.8% 20/96 • Number of events 25 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
General disorders PAIN	2.1% 4/193 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	5.2% 5/96 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
General disorders PYREXIA	16.1% 31/193 • Number of events 40 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	11.5% 11/96 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Immune system disorders HYPOGAMMAGLOBULINAEMIA	5.7% 11/193 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations BRONCHITIS	15.5% 30/193 • Number of events 45 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	15.6% 15/96 • Number of events 20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations CONJUNCTIVITIS	11.4% 22/193 • Number of events 26 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	7.3% 7/96 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations INFLUENZA	14.5% 28/193 • Number of events 38 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	4.2% 4/96 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	7.8% 15/193 • Number of events 19 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	4.2% 4/96 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations NASOPHARYNGITIS	18.1% 35/193 • Number of events 92 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	8.3% 8/96 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations PNEUMONIA	7.3% 14/193 • Number of events 18 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	3.1% 3/96 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations SINUSITIS	5.2% 10/193 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	28.5% 55/193 • Number of events 149 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	26.0% 25/96 • Number of events 46 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Infections and infestations URINARY TRACT INFECTION	7.8% 15/193 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	4.2% 4/96 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications CONTUSION	6.2% 12/193 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	6.2% 6/96 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Injury, poisoning and procedural complications FALL	11.4% 22/193 • Number of events 25 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	8.3% 8/96 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Investigations ALANINE AMINOTRANSFERASE INCREASED	7.8% 15/193 • Number of events 22 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	9.4% 9/96 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	8.8% 17/193 • Number of events 23 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	5.2% 5/96 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Investigations BLOOD CREATININE INCREASED	7.3% 14/193 • Number of events 18 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	2.1% 2/96 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Investigations C-REACTIVE PROTEIN INCREASED	6.7% 13/193 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	3.1% 3/96 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Investigations NEUTROPHIL COUNT DECREASED	10.9% 21/193 • Number of events 54 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	1.0% 1/96 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Investigations PLATELET COUNT DECREASED	17.1% 33/193 • Number of events 78 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	15.6% 15/96 • Number of events 50 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Investigations WEIGHT DECREASED	5.7% 11/193 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	2.1% 2/96 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Metabolism and nutrition disorders DECREASED APPETITE	21.8% 42/193 • Number of events 60 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	13.5% 13/96 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Metabolism and nutrition disorders HYPERGLYCAEMIA	10.4% 20/193 • Number of events 29 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	8.3% 8/96 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Metabolism and nutrition disorders HYPOCALCAEMIA	8.3% 16/193 • Number of events 21 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	0.00% 0/96 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Metabolism and nutrition disorders HYPOKALAEMIA	16.6% 32/193 • Number of events 49 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	8.3% 8/96 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Metabolism and nutrition disorders HYPOMAGNESAEMIA	6.2% 12/193 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	4.2% 4/96 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders ARTHRALGIA	14.0% 27/193 • Number of events 37 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	12.5% 12/96 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders BACK PAIN	22.3% 43/193 • Number of events 48 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	17.7% 17/96 • Number of events 23 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders BONE PAIN	7.8% 15/193 • Number of events 20 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	5.2% 5/96 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	8.8% 17/193 • Number of events 22 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	8.3% 8/96 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders MUSCULAR WEAKNESS	8.8% 17/193 • Number of events 19 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	10.4% 10/96 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL CHEST PAIN	4.7% 9/193 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	6.2% 6/96 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders MUSCULOSKELETAL PAIN	5.2% 10/193 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	3.1% 3/96 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders MYALGIA	6.7% 13/193 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	4.2% 4/96 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	13.0% 25/193 • Number of events 32 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	14.6% 14/96 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Nervous system disorders DIZZINESS	17.6% 34/193 • Number of events 44 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	10.4% 10/96 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Nervous system disorders DYSGEUSIA	8.3% 16/193 • Number of events 18 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	5.2% 5/96 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Nervous system disorders HEADACHE	16.1% 31/193 • Number of events 50 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	16.7% 16/96 • Number of events 19 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Nervous system disorders HYPOAESTHESIA	7.3% 14/193 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	8.3% 8/96 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Nervous system disorders NEUROPATHY PERIPHERAL	30.6% 59/193 • Number of events 84 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	28.1% 27/96 • Number of events 35 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Nervous system disorders PARAESTHESIA	9.3% 18/193 • Number of events 24 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	5.2% 5/96 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Nervous system disorders PERIPHERAL SENSORY NEUROPATHY	18.7% 36/193 • Number of events 60 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	25.0% 24/96 • Number of events 36 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Psychiatric disorders INSOMNIA	29.0% 56/193 • Number of events 73 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	30.2% 29/96 • Number of events 33 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders COUGH	22.8% 44/193 • Number of events 65 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	20.8% 20/96 • Number of events 27 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	11.4% 22/193 • Number of events 33 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	15.6% 15/96 • Number of events 21 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	3.6% 7/193 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	6.2% 6/96 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	4.1% 8/193 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	7.3% 7/96 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	9.3% 18/193 • Number of events 23 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	5.2% 5/96 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders PRODUCTIVE COUGH	7.3% 14/193 • Number of events 25 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	4.2% 4/96 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Respiratory, thoracic and mediastinal disorders RHINORRHOEA	3.1% 6/193 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	5.2% 5/96 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Skin and subcutaneous tissue disorders PRURITUS	17.1% 33/193 • Number of events 47 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	8.3% 8/96 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Skin and subcutaneous tissue disorders RASH	13.0% 25/193 • Number of events 27 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	4.2% 4/96 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Skin and subcutaneous tissue disorders URTICARIA	1.0% 2/193 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	6.2% 6/96 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Vascular disorders HYPERTENSION	10.4% 20/193 • Number of events 23 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	15.6% 15/96 • Number of events 18 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Vascular disorders HYPOTENSION	11.9% 23/193 • Number of events 25 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	4.2% 4/96 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.
Vascular disorders ORTHOSTATIC HYPOTENSION	6.7% 13/193 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.	5.2% 5/96 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow-up was 48.4 months for the venetoclax group and 47.2 months for the placebo group. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 582.2 days and mean time on placebo was 431.3 days. All-cause mortality is reported for all enrolled participants; one participant in each group did not receive treatment.

Additional Information

Global Medical Services

AbbVie

Phone: 800-633-9110

Email: abbvieclinicaltrials@abbvie.com

Results disclosure agreements

• Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
• Publication restrictions are in place

Restriction type: OTHER