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NCT03069352 · ADVERSE EVENTS

Adverse events

A Study of Venetoclax in Combination With Low Dose Cytarabine Versus Low Dose Cytarabine Alone in Treatment Naive Patients With Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy · Source last updated 2025-09-30

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All-cause mortality includes all deaths up to the data cut-off date of 15 August 2019; median time on study was 17.7 months (range: 0.2-20.8) in the placebo arm and 17.5 months (range: 0.1-23.5) in the venetoclax arm. Adverse events are reported from the first dose of study drug up to 30 days after the last dose, to the data cut-off date of 15 August 2019; median duration of treatment was 1.7 months (range: 0.1-20.2) in the placebo arm and 4.1 months (range: 0.0-23.5) in the venetoclax arm.
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Placebo + Low Dose Cytarabine (LDAC)

Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.

42 / 6865 / 6854 / 68
Venetoclax + Low Dose Cytarabine (LDAC)

Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.

95 / 142135 / 14299 / 142

Group identifiers: EG000: Placebo + Low Dose Cytarabine (LDAC) · EG001: Venetoclax + Low Dose Cytarabine (LDAC)

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      142
      num Events
      4
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    DISSEMINATED INTRAVASCULAR COAGULATION
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      68
      num Events
      14
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      142
      num Events
      32
    term
    FEBRILE NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    HYPERLEUKOCYTOSIS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      68
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    LEUKOCYTOSIS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    LEUKOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      142
      num Events
      4
    term
    NEUTROPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      68
      num Events
      2
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      142
      num Events
      8
    term
    THROMBOCYTOPENIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      142
      num Events
      2
    term
    ATRIAL FIBRILLATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      142
      num Events
      0
    term
    CARDIAC ARREST
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    CARDIAC FAILURE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      142
      num Events
      5
    term
    CARDIAC FAILURE ACUTE

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      68
      num Events
      17
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      142
      num Events
      60
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      68
      num Events
      11
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      142
      num Events
      24
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
      num Events
      6
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      142
      num Events
      17
    term
    LEUKOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      68
      num Events
      14
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      142
      num Events
      130
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      68
      num Events
      37
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      142
      num Events
      117
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
      num Events
      3
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      142
      num Events
      17
    term
    ABDOMINAL PAIN
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      68
      num Events
      2
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      142
      num Events
      11
    term
    ABDOMINAL PAIN UPPER
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      68
      num Events
      25
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      142
      num Events
      38
    term
    CONSTIPATION
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      68
      num Events
      15
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      142
      num Events
      70
    term
    DIARRHOEA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      68
      num Events
      2
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      142
      num Events
      11
    term
    DYSPEPSIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      68
      num Events
      27
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      142
      num Events
      95
    term
    NAUSEA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      142
      num Events
      15
    term
    STOMATITIS
Complete source fields
event Groups
  1. deaths Num Affected
    54
    deaths Num At Risk
    68
    description
    Participants received matching placebo to venetoclax orally once a day (QD) plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
    id
    EG000
    other Num Affected
    65
    other Num At Risk
    68
    serious Num Affected
    42
    serious Num At Risk
    68
    title
    Placebo + Low Dose Cytarabine (LDAC)
  2. deaths Num Affected
    99
    deaths Num At Risk
    142
    description
    Participants received venetoclax 600 mg orally once a day plus cytarabine 20 mg/m² subcutaneously on Days 1 to 10 of each 28-day cycle.
    id
    EG001
    other Num Affected
    135
    other Num At Risk
    142
    serious Num Affected
    95
    serious Num At Risk
    142
    title
    Venetoclax + Low Dose Cytarabine (LDAC)
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      68
      num Events
      17
    2. group Id
      EG001
      num Affected
      37
      num At Risk
      142
      num Events
      60
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      68
      num Events
      11
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      142
      num Events
      24
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      68
      num Events
      6
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      142
      num Events
      17
    term
    LEUKOPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      68
      num Events
      14
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      142
      num Events
      130
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      68
      num Events
      37
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      142
      num Events
      117
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
      num Events
      3
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      142
      num Events
      17
    term
    ABDOMINAL PAIN
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      68
      num Events
      2
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      142
      num Events
      11
    term
    ABDOMINAL PAIN UPPER
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      68
      num Events
      25
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      142
      num Events
      38
    term
    CONSTIPATION
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      68
      num Events
      15
    2. group Id
      EG001
      num Affected
      46
      num At Risk
      142
      num Events
      70
    term
    DIARRHOEA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      68
      num Events
      2
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      142
      num Events
      11
    term
    DYSPEPSIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      68
      num Events
      27
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      142
      num Events
      95
    term
    NAUSEA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      142
      num Events
      15
    term
    STOMATITIS
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      142
      num Events
      4
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    DISSEMINATED INTRAVASCULAR COAGULATION
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      68
      num Events
      14
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      142
      num Events
      32
    term
    FEBRILE NEUTROPENIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    HYPERLEUKOCYTOSIS
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      68
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    LEUKOCYTOSIS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    LEUKOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      68
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      142
      num Events
      4
    term
    NEUTROPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      68
      num Events
      2
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      142
      num Events
      8
    term
    THROMBOCYTOPENIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      142
      num Events
      2
    term
    ATRIAL FIBRILLATION
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      142
      num Events
      0
    term
    CARDIAC ARREST
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      68
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      142
      num Events
      1
    term
    CARDIAC FAILURE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      68
      num Events
      1
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      142
      num Events
      5
    term
    CARDIAC FAILURE ACUTE
time Frame
All-cause mortality includes all deaths up to the data cut-off date of 15 August 2019; median time on study was 17.7 months (range: 0.2-20.8) in the placebo arm and 17.5 months (range: 0.1-23.5) in the venetoclax arm. Adverse events are reported from the first dose of study drug up to 30 days after the last dose, to the data cut-off date of 15 August 2019; median duration of treatment was 1.7 months (range: 0.1-20.2) in the placebo arm and 4.1 months (range: 0.0-23.5) in the venetoclax arm.

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