Trial Outcomes & Findings for A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL) (NCT NCT02756611)

Last Updated: 2023-04-10

Results Overview

Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 Modified International Workshop for Chronic Lymphocytic Leukemia National Cancer Institute-Working Group (IWCLL NCI-WG) criteria. CR required all of the following: * Peripheral blood lymphocytes \< 4000/μL * Absence of lymphadenopathy by physical examination and computed tomography scan * No hepatomegaly or splenomegaly by physical examination * Absence of disease or constitutional symptoms (unexplained fevers \> 38°C, drenching night sweats, \> 10% weight loss in last 6 months) * Blood counts above the following: * Neutrophils \> 1500/μL * Platelets \> 100,000/μL * Hemoglobin \> 110 g/L * Bone marrow at least normocellular for age, \< 30% lymphocytes. CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

258 participants

Primary outcome timeframe

From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Results posted on

2023-04-10

Participant Flow

Participants were enrolled at 59 sites in 19 countries. The primary analysis of results occurred after all participants completed the Week 48 disease assessment, with a data cut-off date of 30 June 2019.

Participant milestones

Participant milestones
Measure	Venetoclax Participants received venetoclax on a once daily (QD) dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. In countries where venetoclax was not commercially available, participants who continued to derive benefit after 2 years of treatment could extend their treatment for up to two additional years plus one additional year until the venetoclax extension study was open.
Overall Study STARTED	258
Overall Study COMPLETED	124
Overall Study NOT COMPLETED	134

Reasons for withdrawal

Reasons for withdrawal
Measure	Venetoclax Participants received venetoclax on a once daily (QD) dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. In countries where venetoclax was not commercially available, participants who continued to derive benefit after 2 years of treatment could extend their treatment for up to two additional years plus one additional year until the venetoclax extension study was open.
Overall Study Death	70
Overall Study Withdrawal by Subject	2
Overall Study Lost to Follow-up	3
Overall Study Transitioned to Long-term Extension Study M19-388 (NCT03844048)	49
Overall Study Other	10

Baseline Characteristics

A Study to Evaluate the Efficacy of Venetoclax Monotherapy in Relapsed/Refractory Participants With Chronic Lymphocytic Leukemia (CLL)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Venetoclax n=258 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Age, Continuous	67.7 years STANDARD_DEVIATION 9.04 • n=5 Participants
Age, Customized < 65 years	94 Participants n=5 Participants
Age, Customized >= 65 years	164 Participants n=5 Participants
Sex: Female, Male Female	78 Participants n=5 Participants
Sex: Female, Male Male	180 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	248 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race/Ethnicity, Customized White	252 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants
Race/Ethnicity, Customized Missing	1 Participants n=5 Participants
Geographic Region Europe	161 Participants n=5 Participants
Geographic Region North America	28 Participants n=5 Participants
Geographic Region Rest of the World	69 Participants n=5 Participants
Prior Treatment With B-cell Receptor Inhibitor (BCRi) BCRi-naive	191 Participants n=5 Participants
Prior Treatment With B-cell Receptor Inhibitor (BCRi) BCRi-exposed	67 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Population: All enrolled participants treated with at least one dose of venetoclax who had not previously received treatment with BCRi

Outcome measures

Outcome measures
Measure	Venetoclax n=191 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Primary Analysis	35.1 percentage of participants Interval 28.3 to 42.3

SECONDARY outcome

Timeframe: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Population: All enrolled participants treated with at least one dose of venetoclax who were previously treated with BCRi

Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria. CR required all of the following: * Peripheral blood lymphocytes \< 4000/μL * Absence of lymphadenopathy by physical examination and computed tomography scan * No hepatomegaly or splenomegaly by physical examination * Absence of disease or constitutional symptoms (unexplained fevers \> 38°C, drenching night sweats, \> 10% weight loss in last 6 months) * Blood counts above the following: * Neutrophils \> 1500/μL * Platelets \> 100,000/μL * Hemoglobin \> 110 g/L * Bone marrow at least normocellular for age, \< 30% lymphocytes CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity.

Outcome measures

Outcome measures
Measure	Venetoclax n=67 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Complete Remission Rate in Participants Previously Treated With BCRi Therapy - Primary Analysis	25.4 percentage of participants Interval 15.5 to 37.5

SECONDARY outcome

Timeframe: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Population: All enrolled participants treated with at least one dose of venetoclax

Overall response rate was defined as the percentage of participants with an overall best response of CR, CRi, nodular partial remission (nPR), or confirmed partial remission (PR) based on the 2008 modified IWCLL NCI-WG criteria assessed by the investigator. CR and CRi are defined above. nPR is defined as for CR but bone marrow nodules could be identified histologically. For PR at least 2 of the following must be met: * 50% decrease in peripheral blood lymphocyte count from the Baseline value; * 50% reduction in lymphadenopathy; * 50% reduction in the size of the liver and/or spleen (if abnormal prior to therapy); In addition at least 1 of the following criteria must be met: * Neutrophils \> 1,500/μL or ≥ 50% improvement over Baseline; * Platelets \> 100,000/μL or ≥ 50% improvement over Baseline; * Hemoglobin \> 11.0 g/dL or ≥ 50% improvement over Baseline without transfusions or exogenous growth factors. PR must have been confirmed at least 7 weeks later.

Outcome measures

Outcome measures
Measure	Venetoclax n=258 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Overall Response Rate (ORR) - Primary Analysis	79.8 percentage of participants Interval 74.4 to 84.6

SECONDARY outcome

Timeframe: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Population: Enrolled participants treated with at least one dose of venetoclax who had an overall response of CR, CRi, nPR, or confirmed PR.

Duration of response was defined as the time from the date of first response (CR, CRi, nPR, or PR) to the earliest date that progressive disease (PD) was objectively documented (radiographic or clinical) or death. Duration of response was analyzed by Kaplan-Meier (K-M) methodology. If a participant was still responding the data were censored at the date of the last available disease assessment prior to the data cutoff date.

Outcome measures

Outcome measures
Measure	Venetoclax n=205 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Duration of Overall Response (DOR) - Primary Analysis	25.2 months Interval 23.0 to 25.2

SECONDARY outcome

Timeframe: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Population: Enrolled participants treated with at least one dose of venetoclax

Time to progression was defined as the time from the date of first dose of venetoclax to the date of earliest PD (radiographic or clinical). Participants who did not experience disease progression were censored at the date of the last available disease assessment prior to the data cutoff date; participants with no post-baseline disease assessments were censored at the first dose date plus 1 day. Time to progression was estimated using Kaplan-Meier methodology.

Outcome measures

Outcome measures
Measure	Venetoclax n=258 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Time to Progression (TTP) - Primary Analysis	30.5 months Interval 29.6 to 30.5

SECONDARY outcome

Timeframe: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Population: Enrolled participants treated with at least one dose of venetoclax

Progression-free survival (PFS) was defined as the time from the date of first dose of venetoclax to the date of earliest PD (radiographic or clinical) or death. Participants who did not experience disease progression or death were censored at the date of the last available disease assessment prior to the data cutoff date; participants with no post-baseline tumor assessment or clinical assessment for progression were censored at the date of first dose plus 1 day. Progression-free survival was analyzed by Kaplan-Meier methodology.

Outcome measures

Outcome measures
Measure	Venetoclax n=258 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Progression-Free Survival (PFS) - Primary Analysis	30.5 months Interval 28.6 to 30.5

SECONDARY outcome

Timeframe: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Population: Enrolled participants treated with at least one dose of venetoclax

Overall survival (time to death) was defined as the time from the first dose date of venetoclax to the date of death. If a participant had not died the data were censored at the date when they were last known to be alive prior to the cutoff date. Overall survival was analyzed using Kaplan-Meier methodology.

Outcome measures

Outcome measures
Measure	Venetoclax n=258 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Overall Survival (OS) - Primary Analysis	NA months Could not be estimated due to the low number of events

SECONDARY outcome

Timeframe: Baseline and Weeks 48 and 108

Population: All enrolled participants treated with at least one dose of venetoclax with available data at each time point.

The FACT-Leu is a 44-item, leukemia-specific questionnaire designed to assess health-related quality of life (HRQoL) and leukemia-specific symptoms using a core set of questions (Functional Assessment of Cancer Therapy-General; FACT-G), and a cancer site-specific leukemia subscale. Questions are scored on a scale from 0 (not at all) to 4 (very much). FACT-G consists of 27 general items divided into 4 primary HRQoL domains: Physical Well-being (PWB; 7 items; score range 0-28), Social/Family Well-being (SWB; 7 items; score range 0-28), Emotional Well-being (EWB; 6 items; score range 0-24), Functional Well-being (FWB; 7 items; score range 0-28). The leukemia subscale consists of 17 items (score range 0-68) that assess patient concerns relating to leukemia. Three summary scales were calculated: FACT-Trial Outcome Index composed of the PWB, FWB, and leukemia subscale (score range 0-124); FACT-G (score range 0-108) and the FACT-Leu Total (range 0-176). Higher scores reflect better HRQoL.

Outcome measures

Outcome measures
Measure	Venetoclax n=205 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) Physical well-being - Week 48	1.2 score on a scale Standard Deviation 4.07
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) Physical well-being - Week 108	0.9 score on a scale Standard Deviation 4.20
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) Social/family well-being - Week 48	0.2 score on a scale Standard Deviation 5.14
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) Social/family well-being - Week 108	-0.4 score on a scale Standard Deviation 4.86
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) Emotional well-being - Week 48	2.1 score on a scale Standard Deviation 3.52
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) Emotional well-being - Week 108	1.7 score on a scale Standard Deviation 3.94
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) Functional well-being - Week 48	1.8 score on a scale Standard Deviation 5.63
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) Functional well-being - Week 108	1.4 score on a scale Standard Deviation 5.67
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) Leukemia subscale - Week 48	6.8 score on a scale Standard Deviation 7.99
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) Leukemia subscale - Week 108	6.0 score on a scale Standard Deviation 9.08
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) FACT-G total score - Week 48	5.5 score on a scale Standard Deviation 12.34
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) FACT-G total score - Week 108	3.6 score on a scale Standard Deviation 13.56
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) FACT-leukemia trial outcome index - Week 48	9.8 score on a scale Standard Deviation 14.23
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) FACT-leukemia trial outcome index - Week 108	8.2 score on a scale Standard Deviation 15.61
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) FACT-leukemia total score - Week 48	12.3 score on a scale Standard Deviation 18.18
Change From Baseline in Functional Assessment of Cancer Therapy - Leukemia Questionnaire (FACT-Leu) FACT-leukemia total score - Week 108	9.5 score on a scale Standard Deviation 20.62

SECONDARY outcome

Timeframe: Baseline and Weeks 48 and 108

Population: All enrolled participants treated with at least one dose of venetoclax with available data at each time point.

The FACIT-Fatigue questionnaire measures fatigue and its effect on functioning and daily activities. The FACIT-Fatigue includes 13 items answered on a 5-point rating scale based on a 7-day recall period. Scores range from 0 to 52, with lower scores reflecting greater fatigue.

Outcome measures

Outcome measures
Measure	Venetoclax n=205 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Week 48	4.9 score on a scale Standard Deviation 9.43
Change From Baseline in Functional Assessment of Chronic Illness Therapy - Fatigue Scale (FACIT-Fatigue) Week 108	3.3 score on a scale Standard Deviation 9.96

SECONDARY outcome

Timeframe: Baseline and Weeks 48 and 108

Population: All enrolled participants treated with at least one dose of venetoclax with available data at each time point.

The EQ-5D-5L is a generic measure of health status consisting of two parts: a descriptive system consisting of 5 items and a visual analog scale (VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The participant is asked to rate each dimension on 5 levels of severity (1: no problems, 2: slight problems, 3: moderate problems, 4: severe problems, 5: extreme problems). The scores for the 5 dimensions are used to compute a single health utility index score representing the general health status of the individual. The health index score ranges from zero (defined as a health state equivalent to being dead) to 1 (full health).

Outcome measures

Outcome measures
Measure	Venetoclax n=204 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Health Index Score Week 48	0.0 score on a scale Standard Deviation 0.14
Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Health Index Score Week 108	0.0 score on a scale Standard Deviation 0.15

SECONDARY outcome

Timeframe: Baseline and Weeks 48 and 108

Population: All enrolled participants treated with at least one dose of venetoclax with available data at each time point.

The EQ-5D-5L is a generic measure of health status consisting of two parts, a descriptive system consisting of 5 items and a visual analog scale (VAS). The VAS assesses the participant's self-rated overall health on a scale from 0 (worst health imaginable) to 100 (best health imaginable).

Outcome measures

Outcome measures
Measure	Venetoclax n=204 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Visual Analog Scale Score Week 48	8.5 score on a scale Standard Deviation 14.43
Change From Baseline in EuroQoL 5 Dimension 5 Level Questionnaire (EQ-5D-5L) Visual Analog Scale Score Week 108	7.1 score on a scale Standard Deviation 14.61

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Population: All enrolled participants treated with at least one dose of venetoclax who had not previously received treatment with BCRi

Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria. CR required all of the following: * Peripheral blood lymphocytes \< 4000/μL * Absence of lymphadenopathy by physical examination and computed tomography scan * No hepatomegaly or splenomegaly by physical examination * Absence of disease or constitutional symptoms (unexplained fevers \> 38°C, drenching night sweats, \> 10% weight loss in last 6 months) * Blood counts above the following: * Neutrophils \> 1500/μL * Platelets \> 100,000/μL * Hemoglobin \> 110 g/L * Bone marrow at least normocellular for age, \< 30% lymphocytes. CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity.

Outcome measures

Outcome measures
Measure	Venetoclax n=191 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Complete Remission Rate in Participants Not Previously Treated With BCRi Therapy - Final Analysis	34.6 percentage of participants Interval 27.8 to 41.8

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Population: All enrolled participants treated with at least one dose of venetoclax who were previously treated with BCRi

Complete remission rate is defined as the percentage of participants achieving a best response of complete remission (CR) or complete remission with incomplete marrow recovery (CRi) assessed by the investigator based on 2008 modified IWCLL NCI-WG criteria. CR required all of the following: * Peripheral blood lymphocytes \< 4000/μL * Absence of lymphadenopathy by physical examination and computed tomography scan * No hepatomegaly or splenomegaly by physical examination * Absence of disease or constitutional symptoms (unexplained fevers \> 38°C, drenching night sweats, \> 10% weight loss in last 6 months) * Blood counts above the following: * Neutrophils \> 1500/μL * Platelets \> 100,000/μL * Hemoglobin \> 110 g/L * Bone marrow at least normocellular for age, \< 30% lymphocytes CRi was defined as for CR but with persistent cytopenia apparently unrelated to CLL but related to drug toxicity.

Outcome measures

Outcome measures
Measure	Venetoclax n=67 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Complete Remission Rate in Participants Previously Treated With BCRi Therapy - Final Analysis	26.9 percentage of participants Interval 16.8 to 39.1

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Population: All enrolled participants treated with at least one dose of venetoclax

Outcome measures

Outcome measures
Measure	Venetoclax n=258 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Overall Response Rate (ORR) - Final Analysis	79.8 percentage of participants Interval 74.4 to 84.6

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Population: Enrolled participants treated with at least one dose of venetoclax who had an overall response of CR, CRi, nPR, or confirmed PR.

Outcome measures

Outcome measures
Measure	Venetoclax n=205 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Duration of Overall Response (DOR) - Final Analysis	25.1 months Interval 19.4 to 28.6

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Population: Enrolled participants treated with at least one dose of venetoclax

Outcome measures

Outcome measures
Measure	Venetoclax n=258 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Time to Progression (TTP) - Final Analysis	28.3 months Interval 23.4 to 32.6

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Population: Enrolled participants treated with at least one dose of venetoclax

Outcome measures

Outcome measures
Measure	Venetoclax n=258 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Progression-Free Survival (PFS) - Final Analysis	28.3 months Interval 22.2 to 30.5

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Population: Enrolled participants treated with at least one dose of venetoclax

Outcome measures

Outcome measures
Measure	Venetoclax n=258 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Overall Survival (OS) - Final Analysis	NA months Could not be estimated due to the low number of events

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug until the last participant completed Week 48 assessments (data cut-off date 30 June 2019); overall median time on follow-up was 23.2 months.

Population: All enrolled participants who received at least one dose of venetoclax

The MRD negativity rate is defined as the percentage of participants who had MRD negative status with less than one CLL cell per 10,000 leukocytes (\< 10-⁴) in peripheral blood and bone marrow. MRD was evaluated using next-generation sequencing. Per protocol, peripheral blood MRD assessments were to be collected from all participants at Week 24 and Week 48 and at the time the bone marrow assessment for confirmation of CR/CRi, and bone marrow (BM) MRD assessments were to be collected for participants undergoing a bone marrow procedure for confirmation of CR/CRi. Participants with no blood or BM MRD assessments were included in the calculation of MRD negativity rate as not having MRD negative status.

Outcome measures

Outcome measures
Measure	Venetoclax n=258 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Minimal Residual Disease (MRD) Negativity Rate - Primary Analysis Peripheral blood	39.9 percentage of participants Interval 33.9 to 46.2
Minimal Residual Disease (MRD) Negativity Rate - Primary Analysis Bone marrow	9.7 percentage of participants Interval 6.4 to 14.0

OTHER_PRE_SPECIFIED outcome

Timeframe: From first dose of study drug until the end of study; overall median time on follow-up was 49.5 months.

Population: All enrolled participants who received at least one dose of venetoclax

Outcome measures

Outcome measures
Measure	Venetoclax n=258 Participants Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Minimal Residual Disease (MRD) Negativity Rate - Final Analysis Peripheral blood	40.3 percentage of participants Interval 34.3 to 46.6
Minimal Residual Disease (MRD) Negativity Rate - Final Analysis Bone marrow	10.5 percentage of participants Interval 7.0 to 14.9

Adverse Events

Venetoclax

Serious events: 136 serious events

Other events: 246 other events

Deaths: 70 deaths

Serious adverse events

Serious adverse events
Measure	Venetoclax n=258 participants at risk Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Respiratory, thoracic and mediastinal disorders PLEURAL EFFUSION	1.2% 3/258 • Number of events 4 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders PNEUMONITIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders PULMONARY EMBOLISM	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders PULMONARY HYPERTENSION	0.39% 1/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Skin and subcutaneous tissue disorders PARANEOPLASTIC PEMPHIGUS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Skin and subcutaneous tissue disorders RASH	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Skin and subcutaneous tissue disorders SKIN ULCER	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Vascular disorders ANEURYSM	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Vascular disorders AORTIC INTRAMURAL HAEMATOMA	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Vascular disorders DEEP VEIN THROMBOSIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Vascular disorders HYPERTENSIVE CRISIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Blood and lymphatic system disorders ANAEMIA	1.9% 5/258 • Number of events 5 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Blood and lymphatic system disorders APLASIA PURE RED CELL	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Blood and lymphatic system disorders AUTOIMMUNE HAEMOLYTIC ANAEMIA	1.2% 3/258 • Number of events 6 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Blood and lymphatic system disorders FEBRILE NEUTROPENIA	5.8% 15/258 • Number of events 18 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Blood and lymphatic system disorders GRANULOMATOUS LYMPHADENITIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Blood and lymphatic system disorders HAEMOLYSIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Blood and lymphatic system disorders INTRAVASCULAR HAEMOLYSIS	0.39% 1/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Blood and lymphatic system disorders LEUKOCYTOSIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Blood and lymphatic system disorders NEUTROPENIA	1.6% 4/258 • Number of events 4 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Blood and lymphatic system disorders PANCYTOPENIA	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Blood and lymphatic system disorders THROMBOCYTOPENIA	1.2% 3/258 • Number of events 4 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Cardiac disorders AORTIC VALVE STENOSIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Cardiac disorders ATRIAL FIBRILLATION	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Cardiac disorders ATRIOVENTRICULAR BLOCK	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Cardiac disorders BIFASCICULAR BLOCK	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Cardiac disorders BRADYCARDIA	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Cardiac disorders CARDIAC ARREST	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Cardiac disorders CARDIAC FAILURE	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Cardiac disorders CARDIAC FAILURE CONGESTIVE	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Cardiac disorders CORONARY ARTERY DISEASE	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Cardiac disorders MYOCARDIAL INFARCTION	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Congenital, familial and genetic disorders HYDROCELE	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Ear and labyrinth disorders DEAFNESS NEUROSENSORY	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders ABDOMINAL PAIN	1.2% 3/258 • Number of events 3 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders ASCITES	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders DIARRHOEA	1.9% 5/258 • Number of events 5 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders DIVERTICULUM INTESTINAL HAEMORRHAGIC	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders INGUINAL HERNIA	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders INTESTINAL OBSTRUCTION	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders RECTAL PERFORATION	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders VOMITING	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
General disorders CHEST PAIN	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
General disorders FATIGUE	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
General disorders GENERAL PHYSICAL HEALTH DETERIORATION	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
General disorders MALAISE	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
General disorders MUCOSAL HAEMORRHAGE	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
General disorders MULTIPLE ORGAN DYSFUNCTION SYNDROME	0.78% 2/258 • Number of events 3 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
General disorders PYREXIA	4.3% 11/258 • Number of events 12 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Hepatobiliary disorders BILE DUCT STONE	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Hepatobiliary disorders BILIARY COLIC	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Hepatobiliary disorders CHOLANGITIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Hepatobiliary disorders CHOLELITHIASIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Hepatobiliary disorders GALLBLADDER NECROSIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Hepatobiliary disorders HEPATIC CIRRHOSIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Immune system disorders DRUG HYPERSENSITIVITY	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Immune system disorders HYPERSENSITIVITY	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations ABSCESS LIMB	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations ARTHRITIS BACTERIAL	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations BRONCHIOLITIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations BRONCHITIS	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations CELLULITIS	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations COVID-19	0.78% 2/258 • Number of events 3 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations DIVERTICULITIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations ENDOPHTHALMITIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations EPIDIDYMITIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations ESCHERICHIA INFECTION	0.39% 1/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations GASTROENTERITIS	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations HERPES ZOSTER	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations INFLUENZA	1.2% 3/258 • Number of events 3 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations LOCALISED INFECTION	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations LOWER RESPIRATORY TRACT INFECTION	1.6% 4/258 • Number of events 4 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations NEUTROPENIC SEPSIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations OSTEOMYELITIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations PNEUMONIA	8.1% 21/258 • Number of events 30 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations PNEUMONIA BACTERIAL	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations PYELONEPHRITIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations RESPIRATORY SYNCYTIAL VIRUS INFECTION	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations RESPIRATORY TRACT INFECTION	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations SEPSIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations SEPTIC SHOCK	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations SKIN INFECTION	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations STAPHYLOCOCCAL INFECTION	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations TONSILLITIS BACTERIAL	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations UROSEPSIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Injury, poisoning and procedural complications CLAVICLE FRACTURE	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Injury, poisoning and procedural complications CONTUSION	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Injury, poisoning and procedural complications FALL	0.78% 2/258 • Number of events 4 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Injury, poisoning and procedural complications FEMORAL NECK FRACTURE	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Injury, poisoning and procedural complications FRACTURE	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Injury, poisoning and procedural complications HEAD INJURY	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Injury, poisoning and procedural complications HIP FRACTURE	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Injury, poisoning and procedural complications HUMERUS FRACTURE	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Injury, poisoning and procedural complications INFUSION RELATED REACTION	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Injury, poisoning and procedural complications PELVIC FRACTURE	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Investigations ASPARTATE AMINOTRANSFERASE INCREASED	1.2% 3/258 • Number of events 3 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Investigations BLOOD BILIRUBIN INCREASED	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Investigations BLOOD CREATININE INCREASED	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Investigations BLOOD LACTATE DEHYDROGENASE INCREASED	1.6% 4/258 • Number of events 4 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Investigations BLOOD PHOSPHORUS INCREASED	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Investigations BLOOD POTASSIUM INCREASED	1.2% 3/258 • Number of events 3 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Investigations GENERAL PHYSICAL CONDITION ABNORMAL	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Investigations PLATELET COUNT DECREASED	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Investigations WEIGHT DECREASED	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Metabolism and nutrition disorders CACHEXIA	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Metabolism and nutrition disorders DIABETES MELLITUS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Metabolism and nutrition disorders FLUID RETENTION	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Metabolism and nutrition disorders HYPERGLYCAEMIA	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Metabolism and nutrition disorders HYPERKALAEMIA	1.6% 4/258 • Number of events 7 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	1.2% 3/258 • Number of events 4 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Metabolism and nutrition disorders TUMOUR LYSIS SYNDROME	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Musculoskeletal and connective tissue disorders ARTHRITIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Musculoskeletal and connective tissue disorders BACK PAIN	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Musculoskeletal and connective tissue disorders BONE PAIN	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Musculoskeletal and connective tissue disorders HAEMATOMA MUSCLE	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Musculoskeletal and connective tissue disorders OSTEOARTHRITIS	0.39% 1/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Musculoskeletal and connective tissue disorders OSTEOPOROSIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Musculoskeletal and connective tissue disorders SPINAL PAIN	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADENOMA BENIGN	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) ADRENAL ADENOMA	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BLADDER CANCER	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) BREAST CANCER	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CENTRAL NERVOUS SYSTEM LYMPHOMA	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) CHRONIC LYMPHOCYTIC LEUKAEMIA TRANSFORMATION	0.39% 1/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) DIFFUSE LARGE B-CELL LYMPHOMA	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) INFECTED NEOPLASM	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) LUNG ADENOCARCINOMA	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) MYELODYSPLASTIC SYNDROME	1.6% 4/258 • Number of events 4 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) PROSTATE CANCER	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) RECTAL ADENOCARCINOMA	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SKIN NEOPLASM BLEEDING	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) SQUAMOUS CELL CARCINOMA OF SKIN	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Nervous system disorders ATAXIA	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Nervous system disorders DIZZINESS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Nervous system disorders DYSARTHRIA	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Nervous system disorders FACIAL PARALYSIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Nervous system disorders HAEMORRHAGE INTRACRANIAL	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Nervous system disorders ISCHAEMIC STROKE	0.78% 2/258 • Number of events 3 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Nervous system disorders METABOLIC ENCEPHALOPATHY	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Nervous system disorders SCIATICA	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Nervous system disorders SEIZURE	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Nervous system disorders SOMNOLENCE	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Nervous system disorders SUBARACHNOID HAEMORRHAGE	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Nervous system disorders SYNCOPE	0.78% 2/258 • Number of events 3 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Psychiatric disorders CONFUSIONAL STATE	0.78% 2/258 • Number of events 3 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Psychiatric disorders DEPRESSION	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Psychiatric disorders MENTAL STATUS CHANGES	0.39% 1/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Psychiatric disorders READING DISORDER	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Renal and urinary disorders BLADDER MASS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Reproductive system and breast disorders BENIGN PROSTATIC HYPERPLASIA	1.2% 3/258 • Number of events 3 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Reproductive system and breast disorders PROSTATIC PAIN	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders ACUTE RESPIRATORY FAILURE	0.78% 2/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders ASTHMA	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders ATELECTASIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders BRONCHIECTASIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders CHRONIC OBSTRUCTIVE PULMONARY DISEASE	0.39% 1/258 • Number of events 2 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders COUGH	1.2% 3/258 • Number of events 3 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	1.9% 5/258 • Number of events 5 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders DYSPNOEA EXERTIONAL	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders EPISTAXIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders HAEMOPTYSIS	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders LUNG DISORDER	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders PHARYNGEAL DISORDER	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders PHARYNGEAL SWELLING	0.39% 1/258 • Number of events 1 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.

Other adverse events

Other adverse events
Measure	Venetoclax n=258 participants at risk Participants received venetoclax on a once daily dosing schedule for up to 108 weeks. The starting dose was 20 mg daily, increasing over a period of 5 weeks up to the daily dose of 400 mg. Participants who continued to derive benefit after 2 years of treatment may have continued venetoclax therapy for up to 3 additional years.
Blood and lymphatic system disorders ANAEMIA	22.1% 57/258 • Number of events 84 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Blood and lymphatic system disorders NEUTROPENIA	41.9% 108/258 • Number of events 251 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Blood and lymphatic system disorders THROMBOCYTOPENIA	20.5% 53/258 • Number of events 88 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders ABDOMINAL PAIN	8.1% 21/258 • Number of events 23 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders ABDOMINAL PAIN UPPER	5.0% 13/258 • Number of events 17 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders CONSTIPATION	13.2% 34/258 • Number of events 42 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders DIARRHOEA	36.8% 95/258 • Number of events 170 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders DYSPEPSIA	5.0% 13/258 • Number of events 13 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders NAUSEA	26.7% 69/258 • Number of events 98 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Gastrointestinal disorders VOMITING	7.8% 20/258 • Number of events 24 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
General disorders ASTHENIA	12.4% 32/258 • Number of events 41 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
General disorders FATIGUE	17.4% 45/258 • Number of events 56 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
General disorders OEDEMA PERIPHERAL	5.0% 13/258 • Number of events 17 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
General disorders PYREXIA	16.7% 43/258 • Number of events 56 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations HERPES ZOSTER	5.4% 14/258 • Number of events 17 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations INFLUENZA	5.4% 14/258 • Number of events 14 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations NASOPHARYNGITIS	15.1% 39/258 • Number of events 62 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations PNEUMONIA	6.2% 16/258 • Number of events 19 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	18.2% 47/258 • Number of events 68 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Infections and infestations URINARY TRACT INFECTION	9.7% 25/258 • Number of events 39 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Injury, poisoning and procedural complications FALL	5.0% 13/258 • Number of events 14 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Investigations ALANINE AMINOTRANSFERASE INCREASED	5.0% 13/258 • Number of events 15 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Investigations NEUTROPHIL COUNT DECREASED	10.9% 28/258 • Number of events 47 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Investigations PLATELET COUNT DECREASED	8.1% 21/258 • Number of events 27 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Investigations WEIGHT DECREASED	8.5% 22/258 • Number of events 25 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Metabolism and nutrition disorders DECREASED APPETITE	9.3% 24/258 • Number of events 29 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Metabolism and nutrition disorders HYPERKALAEMIA	8.1% 21/258 • Number of events 31 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Metabolism and nutrition disorders HYPERPHOSPHATAEMIA	7.8% 20/258 • Number of events 23 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Metabolism and nutrition disorders HYPERURICAEMIA	6.6% 17/258 • Number of events 17 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Metabolism and nutrition disorders HYPOCALCAEMIA	5.8% 15/258 • Number of events 19 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Metabolism and nutrition disorders HYPOKALAEMIA	5.8% 15/258 • Number of events 20 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Musculoskeletal and connective tissue disorders ARTHRALGIA	14.3% 37/258 • Number of events 50 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Musculoskeletal and connective tissue disorders BACK PAIN	13.2% 34/258 • Number of events 36 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Musculoskeletal and connective tissue disorders MUSCLE SPASMS	6.6% 17/258 • Number of events 20 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Musculoskeletal and connective tissue disorders PAIN IN EXTREMITY	5.4% 14/258 • Number of events 17 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Nervous system disorders DIZZINESS	7.8% 20/258 • Number of events 26 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Nervous system disorders HEADACHE	10.5% 27/258 • Number of events 29 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Psychiatric disorders INSOMNIA	9.7% 25/258 • Number of events 27 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders COUGH	20.2% 52/258 • Number of events 63 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders DYSPNOEA	8.9% 23/258 • Number of events 26 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Respiratory, thoracic and mediastinal disorders OROPHARYNGEAL PAIN	5.4% 14/258 • Number of events 15 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Skin and subcutaneous tissue disorders DRY SKIN	6.6% 17/258 • Number of events 22 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Skin and subcutaneous tissue disorders PRURITUS	9.7% 25/258 • Number of events 29 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Skin and subcutaneous tissue disorders RASH	7.8% 20/258 • Number of events 33 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.
Vascular disorders HYPERTENSION	11.2% 29/258 • Number of events 34 • All-cause mortality are reported up to the end of the study; median time on study was 210 weeks. Adverse events are reported from the first dose of venetoclax up to 30 days after the last dose of venetoclax; Median (minimum, maximum) duration of treatment was 108 (0.1, 254.6) weeks.

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