Trial Outcomes & Findings for A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy (NCT NCT04266795)
NCT ID: NCT04266795
Last Updated: 2025-10-21
Results Overview
EFS was defined as time from study randomization to date of failure to achieve complete remission (CR)/CR with incomplete blood count recovery (CRi), relapse from CR/CRi, or death. Assessments of disease response based on criteria: European Leukemia Net (ELN) 2017 guidelines. CR was defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC)≥1.0×10\^9/L (1000/µL); platelet count≥100×10\^9/L (100,000/µL). CRi was defined as all CR criteria except for residual neutropenia (\<1.0×10\^9/L \[1000/µL\]) or thrombocytopenia (\<100×10\^9/L \[100,000/µL\]). For participants who achieved CR/CRi, if relapse is not observed by time of analysis, was censored at the date of last disease assessment. If failed to achieve CR/CRi, date of treatment failure was set on day of randomization.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
164 participants
Primary outcome timeframe
Up to 22 months
Results posted on
2025-10-21
Participant Flow
Participants took part in the study at 51 investigative sites in France, Italy, Poland, United States and Canada from 13 October 2020 to 05 January 2024. The data is reported for primary outcome measure up to primary completion date: 06 September 2022. This study is ongoing.
Participants with a diagnosis of Acute Myeloid Leukemia (AML) were randomized in a 1:1 ratio to receive either pevonedistat + venetoclax + azacytidine or venetoclax + azacitidine.
Participant milestones
| Measure |
Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
Venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m\^2 intravenous (IV) or subcutaneous (SC) dosing on Days 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022.
|
Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
Pevonedistat 20 mg/m\^2 as a 60-minute IV infusion on Days 1, 3, and 5 in each 28-day cycle plus venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m\^2 IV or SC dosing on Day 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022.
|
|---|---|---|
|
Overall Study
STARTED
|
81
|
83
|
|
Overall Study
Safety Population
|
80
|
81
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
81
|
83
|
Reasons for withdrawal
| Measure |
Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
Venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m\^2 intravenous (IV) or subcutaneous (SC) dosing on Days 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022.
|
Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
Pevonedistat 20 mg/m\^2 as a 60-minute IV infusion on Days 1, 3, and 5 in each 28-day cycle plus venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m\^2 IV or SC dosing on Day 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022.
|
|---|---|---|
|
Overall Study
Adverse Event
|
10
|
19
|
|
Overall Study
Death
|
7
|
8
|
|
Overall Study
Initiation of Hematopoietic Stem Cell Transplant
|
6
|
2
|
|
Overall Study
Protocol-Specified Withdrawal Criterion Met
|
1
|
0
|
|
Overall Study
Progressive Disease
|
12
|
9
|
|
Overall Study
Withdrawal by Patient
|
5
|
6
|
|
Overall Study
Disease Relapse
|
3
|
6
|
|
Overall Study
Reason not Specified
|
12
|
10
|
|
Overall Study
Participants Ongoing on Treatment
|
25
|
23
|
Baseline Characteristics
A Study of Pevonedistat and Venetoclax Combined With Azacitidine to Treat Acute Myeloid Leukemia (AML) in Adults Unable to Receive Intensive Chemotherapy
Baseline characteristics by cohort
| Measure |
Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
n=81 Participants
Venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m\^2 IV or SC dosing on Days 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022.
|
Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
n=83 Participants
Pevonedistat 20 mg/m\^2 as a 60-minute IV infusion on Days 1, 3, and 5 in each 28-day cycle plus venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m\^2 IV or SC dosing on Day 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022.
|
Total
n=164 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
74.1 years
STANDARD_DEVIATION 5.99 • n=5 Participants
|
74.5 years
STANDARD_DEVIATION 5.01 • n=7 Participants
|
74.3 years
STANDARD_DEVIATION 5.50 • n=5 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
56 Participants
n=5 Participants
|
64 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
24 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
50 Participants
n=5 Participants
|
60 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not reported
|
25 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
3 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
14 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 22 monthsPopulation: ITT population was defined as all participants who were randomized.
EFS was defined as time from study randomization to date of failure to achieve complete remission (CR)/CR with incomplete blood count recovery (CRi), relapse from CR/CRi, or death. Assessments of disease response based on criteria: European Leukemia Net (ELN) 2017 guidelines. CR was defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count (ANC)≥1.0×10\^9/L (1000/µL); platelet count≥100×10\^9/L (100,000/µL). CRi was defined as all CR criteria except for residual neutropenia (\<1.0×10\^9/L \[1000/µL\]) or thrombocytopenia (\<100×10\^9/L \[100,000/µL\]). For participants who achieved CR/CRi, if relapse is not observed by time of analysis, was censored at the date of last disease assessment. If failed to achieve CR/CRi, date of treatment failure was set on day of randomization.
Outcome measures
| Measure |
Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
n=81 Participants
Venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m\^2 intravenous (IV) or subcutaneous (SC) dosing on Days 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022.
|
Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
n=83 Participants
Pevonedistat 20 mg/m\^2 as a 60-minute IV infusion on Days 1, 3, and 5 in each 28-day cycle plus venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m\^2 IV or SC dosing on Day 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022.
|
|---|---|---|
|
Event-Free Survival (EFS)
|
11.24 months
Interval 5.75 to
The upper limit of 95% confidence interval was not estimable due to insufficient number of participants with events.
|
7.72 months
Interval 5.65 to
The upper limit of 95% confidence interval was not estimable due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Up to 36 monthsOS is defined as time from randomization to death from any cause. Participants without documentation of death at the time of analysis will be censored at the date last known to be alive.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 30Mortality rate is defined as percentage of participants who survive at most 30 days from the first dose of study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 60Mortality rate is defined as percentage of participants who survive at most 60 days from the first dose of study drug.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 monthsCR rate is defined as the percentage of participants who achieve the CR as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10\^9/L (1000/µL); platelet count≥100×10\^9/L (100,000/µL).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 monthsCCR rate is defined as the percentage of participants who achieve the CR + CRi as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10\^9/L (1000/µL); platelet count≥100×10\^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (\<1.0×10\^9/L \[1000/µL\]) or thrombocytopenia (\<100×10\^9/L \[100,000/µL\]).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 monthsORR is defined as the percentage of participants who achieve the CR + CRi + Partial Remission (PR) as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10\^9/L (1000/µL); platelet count≥100×10\^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (\<1.0×10\^9/L \[1000/µL\]) or thrombocytopenia (\<100×10\^9/L \[100,000/µL\]). PR is defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 monthsCR + CRh rate is defined as the percentage of participants who achieve the CR + CRh as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥1.0×10\^9/L (1000/µL); platelet count≥100×10\^9/L (100,000/µL). CRh is defined as bone marrow with \<5% blasts, peripheral blood neutrophil count \>0.5×10\^3/µL and peripheral blood platelet count \>0.5×10\^5/µL.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 monthsLeukemia response rate is defined as the percentage of participants who achieve the CR + CRi + PR + morphological leukemia-free state \[MLFS, marrow CR (mCR)\]) as evaluated by the investigator. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥ 1.0×10\^9/L (1000/µL); platelet count≥100×10\^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (\<1.0×10\^9/L \[1000/µL\]) or thrombocytopenia (\<100×10\^9/L \[100,000/µL\]). PR is defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%. MLFS is defined as bone marrow blasts \<5%; absence of blasts with Auer rods; absence of extramedullary disease; no hematologic recovery required.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 monthsDuration of CR and CRi is defined as the time from first documentation of CR or CRi to the date of first documentation of PD or relapse from CR or CRi, and will be summarized descriptively using the K-M method based on the responders. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥ 1.0×10\^9/L (1000/µL); platelet count≥100×10\^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (\<1.0×10\^9/L \[1000/µL\]) or thrombocytopenia (\<100×10\^9/L \[100,000/µL\]).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 36 monthsTime to first CR, CRi, and PR is defined as the time from randomization until the first documented CR, CRi or PR, whichever occurs first, and will be analyzed using the K-M method. Assessments of disease response are based on the criteria outlined in the ELN 2017 guidelines. CR is defined as bone marrow blasts \<5%; absence of circulating blasts and blasts with Auer rods; absence of extramedullary disease; ANC≥ 1.0×10\^9/L (1000/µL); platelet count≥100×10\^9/L (100,000/µL). CRi is defined as all CR criteria except for residual neutropenia (\<1.0×10\^9/L \[1000/µL\]) or thrombocytopenia (\<100×10\^9/L \[100,000/µL\]). PR is defined as all hematologic criteria of CR; decrease of bone marrow blast percentage to 5% to 25%; and decrease of pretreatment bone marrow blast percentage by at least 50%.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: At multiple time points pre-dose and post-dose on Days 1, 3 and 5 in Cycle 1 and post-dose on Day 1 in Cycles 2 and 4 (cycle length= 28 days)Outcome measures
Outcome data not reported
Adverse Events
Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
Serious events: 55 serious events
Other events: 79 other events
Deaths: 15 deaths
Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
Serious events: 62 serious events
Other events: 79 other events
Deaths: 18 deaths
Serious adverse events
| Measure |
Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
n=80 participants at risk
Venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m\^2 IV or SC dosing on Days 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022.
|
Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
n=81 participants at risk
Pevonedistat 20 mg/m\^2 as a 60-minute IV infusion on Days 1, 3, and 5 in each 28-day cycle plus venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m\^2 IV or SC dosing on Day 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Acinetobacter bacteraemia
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Renal and urinary disorders
Acute kidney injury
|
5.0%
4/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Respiratory, thoracic and mediastinal disorders
Acute pulmonary oedema
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Blood and lymphatic system disorders
Anaemia
|
6.2%
5/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
6.2%
5/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Arthritis bacterial
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Asthenia
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Cardiac disorders
Atrial fibrillation
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Bacteraemia
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Cardiac disorders
Bradycardia
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Bronchitis bacterial
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
COVID-19
|
2.5%
2/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
COVID-19 pneumonia
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Vascular disorders
Capillary leak syndrome
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Cardiac disorders
Cardiac arrest
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
3.7%
3/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Cardiac disorders
Cardiogenic shock
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Catheter site cellulitis
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Condition aggravated
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Cryptococcosis
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Ear and labyrinth disorders
Deafness neurosensory
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Death
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Diverticulitis
|
2.5%
2/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Enterobacter bacteraemia
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Enterococcal bacteraemia
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Escherichia sepsis
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
2/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Fatigue
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
2.5%
2/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
25.0%
20/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
17.3%
14/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
General physical health deterioration
|
3.8%
3/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Vascular disorders
Haematoma
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Nervous system disorders
Haemorrhage intracranial
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Blood and lymphatic system disorders
Hyperleukocytosis
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Vascular disorders
Hypotension
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Vascular disorders
Hypotensive crisis
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Infection
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc disorder
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Intervertebral discitis
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Multiple organ dysfunction syndrome
|
2.5%
2/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Blood and lymphatic system disorders
Myelosuppression
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Cardiac disorders
Myocarditis
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Gastrointestinal disorders
Nausea
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Neutropenic sepsis
|
2.5%
2/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
2.5%
2/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Investigations
Platelet count decreased
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Pneumonia
|
12.5%
10/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
8.6%
7/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Pneumonia bacterial
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Pneumonia fungal
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Pneumonia legionella
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Hepatobiliary disorders
Portal vein cavernous transformation
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Gastrointestinal disorders
Proctalgia
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer metastatic
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Pyrexia
|
5.0%
4/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
6.2%
5/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Sepsis
|
8.8%
7/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
7.4%
6/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Septic shock
|
2.5%
2/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
6.2%
5/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Soft tissue inflammation
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Nervous system disorders
Syncope
|
3.8%
3/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Systemic candida
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.0%
8/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Nervous system disorders
Toxic encephalopathy
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Renal and urinary disorders
Urinary retention
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
0.00%
0/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Urinary tract infection
|
2.5%
2/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Gastrointestinal disorders
Vomiting
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
1.2%
1/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
Other adverse events
| Measure |
Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
n=80 participants at risk
Venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m\^2 IV or SC dosing on Days 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022.
|
Pevonedistat 20 mg/m^2 + Venetoclax 100/200/400 mg + Azacitidine 75 mg/m^2
n=81 participants at risk
Pevonedistat 20 mg/m\^2 as a 60-minute IV infusion on Days 1, 3, and 5 in each 28-day cycle plus venetoclax 100 mg tablet orally on Day 1; 200 mg on Day 2; thereafter, at 400 mg on Day 3 through Day 28 in Cycle 1 (cycle length= 28 days) and 400 mg on Days 1 through 28 in Cycle 2 and beyond if tolerated. Following the confirmation of remission in Cycle 1 or thereafter, venetoclax 400 mg was administered on Day 1 through 21 or 28 as per Investigator's discretion, plus azacitidine 75 mg/m\^2 IV or SC dosing on Day 1 through 7 or Days 1 through 5, Days 8, and 9 in each cycle up to primary completion date: 06 September 2022.
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
12.5%
10/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
12.3%
10/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Investigations
Alanine aminotransferase increased
|
5.0%
4/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
7.4%
6/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Blood and lymphatic system disorders
Anaemia
|
40.0%
32/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
37.0%
30/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Psychiatric disorders
Anxiety
|
1.2%
1/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
7.4%
6/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.0%
8/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
12.3%
10/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
4/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
9.9%
8/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Asthenia
|
20.0%
16/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
17.3%
14/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Cardiac disorders
Atrial fibrillation
|
8.8%
7/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
10.0%
8/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
7.4%
6/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Investigations
Blood bilirubin increased
|
3.8%
3/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
8.6%
7/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Investigations
Blood creatinine increased
|
15.0%
12/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
9.9%
8/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Chills
|
5.0%
4/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
8.6%
7/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Gastrointestinal disorders
Constipation
|
32.5%
26/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
42.0%
34/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.2%
5/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
7.4%
6/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.8%
7/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
6.2%
5/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.8%
15/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
9.9%
8/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Gastrointestinal disorders
Diarrhoea
|
31.2%
25/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
34.6%
28/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Nervous system disorders
Dizziness
|
7.5%
6/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
6.2%
5/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
8.8%
7/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
17.3%
14/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
8/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
7.4%
6/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Injury, poisoning and procedural complications
Fall
|
2.5%
2/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
7.4%
6/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Fatigue
|
10.0%
8/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
12.3%
10/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
20.0%
16/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
14.8%
12/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Gastrointestinal disorders
Haemorrhoids
|
11.2%
9/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
7.4%
6/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Nervous system disorders
Headache
|
8.8%
7/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
13.6%
11/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
5.0%
4/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
7.4%
6/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
8.8%
7/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
9.9%
8/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
6.2%
5/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
3.7%
3/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Vascular disorders
Hypertension
|
5.0%
4/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
8.6%
7/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
6.2%
5/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
9.9%
8/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
13.8%
11/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
13.6%
11/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
32.5%
26/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
32.1%
26/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
11.2%
9/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
9.9%
8/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.5%
6/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
11.1%
9/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
7.5%
6/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
14.8%
12/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Vascular disorders
Hypotension
|
12.5%
10/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
14.8%
12/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
3.8%
3/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
6.2%
5/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Injection site erythema
|
7.5%
6/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Injection site pain
|
6.2%
5/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Psychiatric disorders
Insomnia
|
10.0%
8/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
7.4%
6/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Blood and lymphatic system disorders
Leukopenia
|
15.0%
12/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
12.3%
10/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Investigations
Lymphocyte count decreased
|
6.2%
5/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
4.9%
4/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Gastrointestinal disorders
Nausea
|
40.0%
32/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
30.9%
25/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Blood and lymphatic system disorders
Neutropenia
|
57.5%
46/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
58.0%
47/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Investigations
Neutrophil count decreased
|
10.0%
8/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
8.6%
7/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Oedema peripheral
|
15.0%
12/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
22.2%
18/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
7.5%
6/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
4.9%
4/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Investigations
Platelet count decreased
|
10.0%
8/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
6.2%
5/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Infections and infestations
Pneumonia
|
8.8%
7/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
14.8%
12/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.0%
4/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
8.6%
7/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
General disorders
Pyrexia
|
17.5%
14/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
27.2%
22/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.5%
2/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
6.2%
5/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
38.8%
31/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
45.7%
37/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
7.5%
6/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
2.5%
2/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Gastrointestinal disorders
Vomiting
|
31.2%
25/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
16.0%
13/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
|
|
Investigations
White blood cell count decreased
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8.8%
7/80 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
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9.9%
8/81 • From signing of informed consent to 30 days post last dose, up to primary completion date: 06 September 2022 (up to 22 months 24 days)
At each visit the investigator had to document any occurrence of adverse events and abnormal laboratory findings. Any event spontaneously reported by the participant or observed by the investigator was recorded, irrespective of the relation to study treatment. Safety population was defined as all participants who received at least 1 dose of pevonedistat combination or azacitidine + venetoclax.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
- Publication restrictions are in place
Restriction type: OTHER