Skip to content
Triangle logo TriangleGet started
← Full study record

NCT02993523 · ADVERSE EVENTS

Adverse events

A Study of Venetoclax in Combination With Azacitidine Versus Azacitidine in Treatment Naïve Participants With Acute Myeloid Leukemia Who Are Ineligible for Standard Induction Therapy · Source last updated 2026-06-11

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
From the study start until data cut-off date: 01 December 2021 (up to approximately 4.8 years)
Other-event reporting threshold
5%

Safety analysis set included all Group 1 and Group 2 participants (exclude the open-label China safety cohort) who took at least one dose of venetoclax/placebo and azacitidine combination. As pre-specified in SAP the data is reported combined for both Group 1 and Group 2 participants who received either placebo plus azacitidine or venetoclax plus azacitidine. Open-Label China Safety Cohort included participants who received at least one dose of venetoclax in combination with azacitidine.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2

Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).

111 / 144137 / 144140 / 144
Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2

Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).

242 / 283279 / 283226 / 283
Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2

Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).

7 / 1010 / 106 / 10

Group identifiers: EG000: Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2 · EG001: Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2 · EG002: Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2

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
      9
      num At Risk
      144
      num Events
      13
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      283
      num Events
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    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
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      283
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    CYTOPENIA
  3. 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
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      283
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    DISSEMINATED INTRAVASCULAR COAGULATION
  4. 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
      144
      num Events
      21
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      283
      num Events
      132
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    FEBRILE 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
      0
      num At Risk
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      283
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    HAEMOLYSIS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      144
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      283
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    LEUKOCYTOSIS
  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
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      283
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    LEUKOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      144
      num Events
      4
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      283
      num Events
      15
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
      num Events
      3
    term
    NEUTROPENIA
  9. 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
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      283
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    PANCYTOPENIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      144
      num Events
      3
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      283
      num Events
      14
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
      num Events
      4
    term
    THROMBOCYTOPENIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      144
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      283
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    ACUTE CORONARY SYNDROME
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      144
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      283
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    ACUTE MYOCARDIAL INFARCTION

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
      24
      num At Risk
      144
      num Events
      30
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      283
      num Events
      102
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      10
      num Events
      11
    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
      12
      num At Risk
      144
      num Events
      16
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      283
      num Events
      44
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
      num Events
      3
    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
      20
      num At Risk
      144
      num Events
      46
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      283
      num Events
      133
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      10
      num Events
      20
    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
      2
      num At Risk
      144
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      283
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    LYMPHADENOPATHY
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      144
      num Events
      6
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      283
      num Events
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    LYMPHOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      144
      num Events
      66
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      283
      num Events
      245
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      10
      num Events
      6
    term
    NEUTROPENIA
  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
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      283
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    SPLENIC INFARCTION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      144
      num Events
      94
    2. group Id
      EG001
      num Affected
      120
      num At Risk
      283
      num Events
      246
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      10
      num Events
      15
    term
    THROMBOCYTOPENIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      283
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    ANGINA PECTORIS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      144
      num Events
      15
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      283
      num Events
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    ATRIAL FIBRILLATION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      283
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    CARDIAC FAILURE CONGESTIVE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      283
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    VESTIBULAR DISORDER
Complete source fields
description
Safety analysis set included all Group 1 and Group 2 participants (exclude the open-label China safety cohort) who took at least one dose of venetoclax/placebo and azacitidine combination. As pre-specified in SAP the data is reported combined for both Group 1 and Group 2 participants who received either placebo plus azacitidine or venetoclax plus azacitidine. Open-Label China Safety Cohort included participants who received at least one dose of venetoclax in combination with azacitidine.
event Groups
  1. deaths Num Affected
    140
    deaths Num At Risk
    144
    description
    Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax-matching placebo, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
    id
    EG000
    other Num Affected
    137
    other Num At Risk
    144
    serious Num Affected
    111
    serious Num At Risk
    144
    title
    Group 1 and Group 2: Placebo + Azacitidine 75 mg/m^2
  2. deaths Num Affected
    226
    deaths Num At Risk
    283
    description
    Participants enrolled under original protocol and enrolled during or after protocol amendment 1 received venetoclax 100 mg, once orally, on Day 1 of Cycle 1 followed by venetoclax 200 mg, once orally, on Day 2 of Cycle 1 and venetoclax 400 mg, orally, QD, on Day 3 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC or IV, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
    id
    EG001
    other Num Affected
    279
    other Num At Risk
    283
    serious Num Affected
    242
    serious Num At Risk
    283
    title
    Group 1 and Group 2: Venetoclax 100 mg/200 mg/400 mg + Azacitidine 75 mg/m^2
  3. deaths Num Affected
    6
    deaths Num At Risk
    10
    description
    Participants received venetoclax 400 mg, orally, QD, from Day 1 to Day 28 of each 28 day cycle along with azacitidine 75 mg/m\^2, SC, QD for 7 days from Day 1 of each 28-day cycle until documented disease progression, unacceptable toxicity, withdrawal of consent, or other protocol criteria for discontinuation (whichever occurred first).
    id
    EG002
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    7
    serious Num At Risk
    10
    title
    Open Label China Cohort: Venetoclax 400 mg + Azacitidine 75 mg/m^2
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
      24
      num At Risk
      144
      num Events
      30
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      283
      num Events
      102
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      10
      num Events
      11
    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
      12
      num At Risk
      144
      num Events
      16
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      283
      num Events
      44
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
      num Events
      3
    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
      20
      num At Risk
      144
      num Events
      46
    2. group Id
      EG001
      num Affected
      54
      num At Risk
      283
      num Events
      133
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      10
      num Events
      20
    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
      2
      num At Risk
      144
      num Events
      2
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      283
      num Events
      4
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    LYMPHADENOPATHY
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      144
      num Events
      6
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      283
      num Events
      16
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    LYMPHOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      144
      num Events
      66
    2. group Id
      EG001
      num Affected
      107
      num At Risk
      283
      num Events
      245
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      10
      num Events
      6
    term
    NEUTROPENIA
  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
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      283
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    SPLENIC INFARCTION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      144
      num Events
      94
    2. group Id
      EG001
      num Affected
      120
      num At Risk
      283
      num Events
      246
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      10
      num Events
      15
    term
    THROMBOCYTOPENIA
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      283
      num Events
      3
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    ANGINA PECTORIS
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      144
      num Events
      15
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      283
      num Events
      26
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    ATRIAL FIBRILLATION
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      283
      num Events
      5
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    CARDIAC FAILURE CONGESTIVE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      283
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      10
      num Events
      1
    term
    VESTIBULAR DISORDER
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
      9
      num At Risk
      144
      num Events
      13
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      283
      num Events
      23
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    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
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      283
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    CYTOPENIA
  3. 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
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      283
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    DISSEMINATED INTRAVASCULAR COAGULATION
  4. 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
      144
      num Events
      21
    2. group Id
      EG001
      num Affected
      88
      num At Risk
      283
      num Events
      132
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      10
      num Events
      2
    term
    FEBRILE 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
      0
      num At Risk
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      283
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    HAEMOLYSIS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      144
      num Events
      3
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      283
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    LEUKOCYTOSIS
  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
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      283
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    LEUKOPENIA
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      144
      num Events
      4
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      283
      num Events
      15
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
      num Events
      3
    term
    NEUTROPENIA
  9. 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
      144
      num Events
      0
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      283
      num Events
      5
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    PANCYTOPENIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      144
      num Events
      3
    2. group Id
      EG001
      num Affected
      14
      num At Risk
      283
      num Events
      14
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      10
      num Events
      4
    term
    THROMBOCYTOPENIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      144
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      283
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    ACUTE CORONARY SYNDROME
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 21.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      144
      num Events
      4
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      283
      num Events
      2
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      10
      num Events
      0
    term
    ACUTE MYOCARDIAL INFARCTION
time Frame
From the study start until data cut-off date: 01 December 2021 (up to approximately 4.8 years)

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice