Trial Outcomes & Findings for A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy (NCT NCT03941964)
NCT ID: NCT03941964
Last Updated: 2023-03-20
Results Overview
The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at any time during the study as assessed by the investigator. Response was based on bone marrow results and hematology values according to the modified International Working Group (IWG) criteria for AML: CR: Absolute neutrophil count (ANC) \> 10\^3/μL (1,000/μL), platelets \> 10\^5/μL (100,000/μL), red blood cell (RBC) transfusion independence, and bone marrow with \< 5% blasts CRi: Bone marrow with \< 5% blasts, and absolute neutrophils of ≤ 10\^3/μL or platelets ≤ 10\^5/μL
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
60 participants
Primary outcome timeframe
Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively.
Results posted on
2023-03-20
Participant Flow
All participants who received at least one dose of venetoclax and azacitidine or decitabine; this study disposition represents the primary reason for venetoclax discontinuation
Participant milestones
| Measure |
Venetoclax 400 mg + Azacitidine 75 mg
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m\^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle.
|
Venetoclax 400 mg + Decitabine 20 mg
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m\^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
7
|
11
|
|
Overall Study
NOT COMPLETED
|
23
|
19
|
Reasons for withdrawal
| Measure |
Venetoclax 400 mg + Azacitidine 75 mg
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m\^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle.
|
Venetoclax 400 mg + Decitabine 20 mg
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m\^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle.
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
8
|
|
Overall Study
Progressive disease
|
7
|
3
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Death
|
3
|
1
|
|
Overall Study
Withdrew consent
|
1
|
3
|
|
Overall Study
Physician Decision
|
9
|
2
|
|
Overall Study
Other, not specified
|
2
|
1
|
Baseline Characteristics
A Study of the Effectiveness of Venetoclax in Combination With Azacitidine or Decitabine in an Outpatient Setting in Patients With Acute Myeloid Leukemia (AML) Ineligible for Intensive Chemotherapy
Baseline characteristics by cohort
| Measure |
Venetoclax 400 mg + Azacitidine 75 mg
n=30 Participants
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m\^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle.
|
Venetoclax 400 mg + Decitabine 20 mg
n=30 Participants
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m\^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
77.0 years
STANDARD_DEVIATION 6.31 • n=5 Participants
|
76.2 years
STANDARD_DEVIATION 6.35 • n=7 Participants
|
76.6 years
STANDARD_DEVIATION 6.29 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
31 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
26 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
55 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively.Population: All participants who received at least one dose of venetoclax and azacitidine or decitabine
The composite complete remission rate is defined as the percentage of participants with complete remission (CR) or complete remission with incomplete blood count recovery (CRi) at any time during the study as assessed by the investigator. Response was based on bone marrow results and hematology values according to the modified International Working Group (IWG) criteria for AML: CR: Absolute neutrophil count (ANC) \> 10\^3/μL (1,000/μL), platelets \> 10\^5/μL (100,000/μL), red blood cell (RBC) transfusion independence, and bone marrow with \< 5% blasts CRi: Bone marrow with \< 5% blasts, and absolute neutrophils of ≤ 10\^3/μL or platelets ≤ 10\^5/μL
Outcome measures
| Measure |
Venetoclax 400 mg + Azacitidine 75 mg
n=30 Participants
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m\^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle.
|
Venetoclax 400 mg + Decitabine 20 mg
n=30 Participants
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m\^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle.
|
|---|---|---|
|
Percentage of Participants With Complete Remission or Complete Remission With Incomplete Blood Count Recovery (CR + CRi)
|
70.0 percentage of participants
Interval 50.6 to 85.3
|
63.3 percentage of participants
Interval 43.9 to 80.1
|
SECONDARY outcome
Timeframe: Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively.Population: All participants who received at least one dose of venetoclax and azacitidine or decitabine
The complete remission rate is defined as the percentage of participants with complete remission (CR) at any time during the study as assessed by the investigator. Response was based on bone marrow results and hematology values according to the modified International Working Group (IWG) criteria for AML: CR: Absolute neutrophil count (ANC) \> 10\^3/μL (1,000/μL), platelets \> 10\^5/μL (100,000/μL), red blood cell (RBC) transfusion independence, and bone marrow with \< 5% blasts
Outcome measures
| Measure |
Venetoclax 400 mg + Azacitidine 75 mg
n=30 Participants
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m\^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle.
|
Venetoclax 400 mg + Decitabine 20 mg
n=30 Participants
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m\^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle.
|
|---|---|---|
|
Percentage of Participants With Complete Remission (CR)
|
13.3 percentage of participants
Interval 3.8 to 30.7
|
26.7 percentage of participants
Interval 12.3 to 45.9
|
SECONDARY outcome
Timeframe: Assessed at Cycle 1 end, at Cycle 2 end if CR/CRi wasn't achieved at Cycle 1 end, or Cycle 4 end if CR/CRi wasn't achieved at Cycle 2 end. Median treatment duration of venetoclax was 16.1 wks (range 3.9-38.1) and 21.1 wks (range 2.7-40.4), respectively.Population: All participants who received at least one dose of venetoclax and azacitidine or decitabine
The complete remission with incomplete blood count recovery rate is defined as the percentage of participants with complete remission with incomplete blood count recovery (CRi) at any time during the study as assessed by the investigator. Response was based on bone marrow results and hematology values according to the modified International Working Group (IWG) criteria for AML: CRi: Bone marrow with \< 5% blasts, and absolute neutrophils of ≤ 10\^3/μL or platelets ≤ 10\^5/μL.
Outcome measures
| Measure |
Venetoclax 400 mg + Azacitidine 75 mg
n=30 Participants
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m\^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle.
|
Venetoclax 400 mg + Decitabine 20 mg
n=30 Participants
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m\^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle.
|
|---|---|---|
|
Percentage of Participants With Complete Remission With Incomplete Blood Count Recovery (CRi)
|
56.7 percentage of participants
Interval 37.4 to 74.5
|
36.7 percentage of participants
Interval 19.9 to 56.1
|
SECONDARY outcome
Timeframe: From the first dose of study drug to the last dose of study drug +30 days, or death, or initiation of post-treatment therapy, whichever occurred earliest. Median time on follow-up was 183.5 days and 195.0 days, respectively.Population: All participants who received at least one dose of venetoclax and azacitidine or decitabine
The transfusion independence rate is defined as the percentage of participants with post-baseline transfusion independence, which is defined as a period of at least 56 days with no transfusion after the first dose of study drug and within 30 days of the last dose of study drug, death, or initiation of post-treatment therapy, whichever is earliest.
Outcome measures
| Measure |
Venetoclax 400 mg + Azacitidine 75 mg
n=30 Participants
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m\^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle.
|
Venetoclax 400 mg + Decitabine 20 mg
n=30 Participants
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m\^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle.
|
|---|---|---|
|
Percentage of Participants With Post-baseline Transfusion Independence
Red blood cells (RBC)
|
50.0 percentage of participants
Interval 31.3 to 68.7
|
60.0 percentage of participants
Interval 40.6 to 77.3
|
|
Percentage of Participants With Post-baseline Transfusion Independence
Platelets
|
73.3 percentage of participants
Interval 54.1 to 87.7
|
73.3 percentage of participants
Interval 54.1 to 87.7
|
|
Percentage of Participants With Post-baseline Transfusion Independence
RBC and platelets
|
50.0 percentage of participants
Interval 31.3 to 68.7
|
60.0 percentage of participants
Interval 40.6 to 77.3
|
Adverse Events
Venetoclax 400 mg + Azacitidine 75 mg
Serious events: 19 serious events
Other events: 29 other events
Deaths: 5 deaths
Venetoclax 400 mg + Decitabine 20 mg
Serious events: 22 serious events
Other events: 30 other events
Deaths: 8 deaths
Venetoclax 400 mg + Azacitidine 75 mg or Decitabine 20 mg
Serious events: 41 serious events
Other events: 59 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
Venetoclax 400 mg + Azacitidine 75 mg
n=30 participants at risk
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m\^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle.
|
Venetoclax 400 mg + Decitabine 20 mg
n=30 participants at risk
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m\^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle.
|
Venetoclax 400 mg + Azacitidine 75 mg or Decitabine 20 mg
n=60 participants at risk
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m\^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle. Decitabine (20 mg/m\^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
26.7%
8/30 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
33.3%
10/30 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
30.0%
18/60 • Number of events 23 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Blood and lymphatic system disorders
LEUKOPENIA
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Cardiac disorders
ACUTE MYOCARDIAL INFARCTION
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Cardiac disorders
ATRIAL FLUTTER
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Cardiac disorders
CARDIAC FAILURE
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Cardiac disorders
CARDIAC FAILURE CONGESTIVE
|
6.7%
2/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Cardiac disorders
SINUS TACHYCARDIA
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Ear and labyrinth disorders
VERTIGO
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Gastrointestinal disorders
PROCTALGIA
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
General disorders
ASTHENIA
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
General disorders
DEATH
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
4/60 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
General disorders
DISEASE PROGRESSION
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
General disorders
PYREXIA
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
COVID-19
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
ENTEROCOLITIS INFECTIOUS
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
ESCHERICHIA BACTERAEMIA
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
ESCHERICHIA SEPSIS
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
PERINEAL ABSCESS
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
PNEUMONIA
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
SEPSIS
|
6.7%
2/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
26.7%
8/30 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
16.7%
10/60 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
SEPTIC SHOCK
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
SKIN INFECTION
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Injury, poisoning and procedural complications
LUMBAR VERTEBRAL FRACTURE
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Injury, poisoning and procedural complications
SUBDURAL HAEMATOMA
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Metabolism and nutrition disorders
TUMOUR LYSIS SYNDROME
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
3.3%
1/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Nervous system disorders
DIZZINESS
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Nervous system disorders
GUILLAIN-BARRE SYNDROME
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Renal and urinary disorders
ACUTE KIDNEY INJURY
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
1.7%
1/60 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Vascular disorders
HYPOTENSION
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
Other adverse events
| Measure |
Venetoclax 400 mg + Azacitidine 75 mg
n=30 participants at risk
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m\^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle.
|
Venetoclax 400 mg + Decitabine 20 mg
n=30 participants at risk
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Decitabine (20 mg/m\^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle.
|
Venetoclax 400 mg + Azacitidine 75 mg or Decitabine 20 mg
n=60 participants at risk
Participants received venetoclax orally daily for 28-day cycles, for a maximum of 6 cycles, beginning on Cycle 1 Day 1. The venetoclax dosing ramp-up schedule was 100 mg on Cycle 1 Day 1, 200 mg on Cycle 1 Day 2, and 400 mg on Cycle 1 Days 3 -28 and 400 mg daily for each 28-day cycle thereafter. Azacitidine (75 mg/m\^2) was administered subcutaneously or intravenously per investigator's choice and institutional practice for 7 days beginning on Day 1 of each 28-day cycle. Decitabine (20 mg/m\^2) was administered intravenously per investigator's choice and institutional practice for 5 days beginning on Day 1 of each cycle.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
76.7%
23/30 • Number of events 46 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
80.0%
24/30 • Number of events 79 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
78.3%
47/60 • Number of events 125 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Blood and lymphatic system disorders
FEBRILE NEUTROPENIA
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
10.0%
3/30 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
30.0%
9/30 • Number of events 18 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
20.0%
12/60 • Number of events 23 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
10.0%
3/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
33.3%
10/30 • Number of events 23 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
21.7%
13/60 • Number of events 27 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Cardiac disorders
ATRIAL FIBRILLATION
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
4/60 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
20.0%
6/30 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
13.3%
8/60 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Gastrointestinal disorders
CONSTIPATION
|
36.7%
11/30 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
26.7%
8/30 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
31.7%
19/60 • Number of events 25 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Gastrointestinal disorders
DIARRHOEA
|
40.0%
12/30 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
36.7%
11/30 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
38.3%
23/60 • Number of events 30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Gastrointestinal disorders
GASTROOESOPHAGEAL REFLUX DISEASE
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
13.3%
4/30 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
11.7%
7/60 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Gastrointestinal disorders
GINGIVAL BLEEDING
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Gastrointestinal disorders
HAEMORRHOIDS
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
4/60 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Gastrointestinal disorders
NAUSEA
|
56.7%
17/30 • Number of events 23 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
50.0%
15/30 • Number of events 22 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
53.3%
32/60 • Number of events 45 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Gastrointestinal disorders
STOMATITIS
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
13.3%
4/30 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
11.7%
7/60 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Gastrointestinal disorders
VOMITING
|
43.3%
13/30 • Number of events 15 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
10.0%
3/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
26.7%
16/60 • Number of events 19 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
General disorders
CHEST PAIN
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
General disorders
CHILLS
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
13.3%
4/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
4/60 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
General disorders
FATIGUE
|
43.3%
13/30 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
40.0%
12/30 • Number of events 18 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
41.7%
25/60 • Number of events 32 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
General disorders
INJECTION SITE REACTION
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
General disorders
MALAISE
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
General disorders
OEDEMA PERIPHERAL
|
26.7%
8/30 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
23.3%
7/30 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
25.0%
15/60 • Number of events 18 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
General disorders
PYREXIA
|
20.0%
6/30 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
23.3%
7/30 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
21.7%
13/60 • Number of events 16 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
BRONCHOPULMONARY ASPERGILLOSIS
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
COVID-19
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
FUNGAL SKIN INFECTION
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
PNEUMONIA
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
4/60 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
SINUSITIS
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
13.3%
4/30 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
8.3%
5/60 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
4/60 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Injury, poisoning and procedural complications
FALL
|
16.7%
5/30 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
16.7%
5/30 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
16.7%
10/60 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Investigations
ALANINE AMINOTRANSFERASE INCREASED
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
4/60 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Investigations
ASPARTATE AMINOTRANSFERASE INCREASED
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
4/60 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Investigations
BLOOD BILIRUBIN INCREASED
|
10.0%
3/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
13.3%
4/30 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
11.7%
7/60 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Investigations
BLOOD CREATININE INCREASED
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Investigations
LYMPHOCYTE COUNT DECREASED
|
6.7%
2/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
13.3%
4/30 • Number of events 46 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
10.0%
6/60 • Number of events 49 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Investigations
NEUTROPHIL COUNT DECREASED
|
63.3%
19/30 • Number of events 54 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
50.0%
15/30 • Number of events 92 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
56.7%
34/60 • Number of events 146 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Investigations
PLATELET COUNT DECREASED
|
46.7%
14/30 • Number of events 54 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
53.3%
16/30 • Number of events 80 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
50.0%
30/60 • Number of events 134 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Investigations
WEIGHT DECREASED
|
26.7%
8/30 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
15.0%
9/60 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Investigations
WHITE BLOOD CELL COUNT DECREASED
|
50.0%
15/30 • Number of events 45 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
53.3%
16/30 • Number of events 114 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
51.7%
31/60 • Number of events 159 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
33.3%
10/30 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
20.0%
12/60 • Number of events 12 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
8.3%
5/60 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Metabolism and nutrition disorders
HYPERGLYCAEMIA
|
3.3%
1/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Metabolism and nutrition disorders
HYPERPHOSPHATAEMIA
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
10.0%
3/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
4/60 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
23.3%
7/30 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
16.7%
10/60 • Number of events 14 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
3.3%
1/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
10.0%
3/30 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
8.3%
5/60 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
16.7%
5/30 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
11.7%
7/60 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
13.3%
4/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
13.3%
4/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
13.3%
8/60 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Musculoskeletal and connective tissue disorders
BONE PAIN
|
6.7%
2/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Musculoskeletal and connective tissue disorders
FLANK PAIN
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
6.7%
2/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
13.3%
4/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
11.7%
7/60 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Musculoskeletal and connective tissue disorders
NECK PAIN
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
13.3%
4/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
8.3%
5/60 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Nervous system disorders
DIZZINESS
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
16.7%
5/30 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
13.3%
8/60 • Number of events 9 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Nervous system disorders
HEADACHE
|
13.3%
4/30 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
13.3%
4/30 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
13.3%
8/60 • Number of events 10 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Nervous system disorders
PRESYNCOPE
|
6.7%
2/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Psychiatric disorders
ANXIETY
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Psychiatric disorders
DEPRESSION
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
8.3%
5/60 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Psychiatric disorders
INSOMNIA
|
16.7%
5/30 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
20.0%
6/30 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
18.3%
11/60 • Number of events 13 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Renal and urinary disorders
DYSURIA
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
20.0%
6/30 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
16.7%
5/30 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
18.3%
11/60 • Number of events 11 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
EPISTAXIS
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
10.0%
3/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
4/60 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
HYPOXIA
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
10.0%
3/30 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
4/60 • Number of events 6 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
NASAL CONGESTION
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
13.3%
4/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
4/60 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Respiratory, thoracic and mediastinal disorders
WHEEZING
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Skin and subcutaneous tissue disorders
ERYTHEMA
|
3.3%
1/30 • Number of events 1 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
5.0%
3/60 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
10.0%
3/30 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
8.3%
5/60 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
13.3%
4/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
4/60 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Skin and subcutaneous tissue disorders
RASH MACULO-PAPULAR
|
6.7%
2/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
10.0%
3/30 • Number of events 4 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
8.3%
5/60 • Number of events 7 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Vascular disorders
DEEP VEIN THROMBOSIS
|
0.00%
0/30 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
6.7%
2/30 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
3.3%
2/60 • Number of events 2 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
|
Vascular disorders
HYPOTENSION
|
10.0%
3/30 • Number of events 3 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
13.3%
4/30 • Number of events 5 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
11.7%
7/60 • Number of events 8 • All-cause mortality is reported from enrollment to end of study; median time on follow up was 183.5, 195.0 and 195.0 days, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean time on venetoclax was 18.2, 18.6, and 18.4 weeks, respectively.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER