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NCT02287233 · ADVERSE EVENTS

Adverse events

A Study Evaluating Venetoclax in Combination With Low-Dose Cytarabine in Treatment-Naïve Participants With Acute Myelogenous Leukemia · Source last updated 2022-08-29

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 is reported from enrollment through the end of study; maximum time on study was 63.7 months. Adverse events are reported from first dose of study drug until 30 days after last dose of study drug; median (minimum, maximum) duration of treatment was 4.1 (0.2, 62.8) months overall.
Other-event reporting threshold
5%

All-cause mortality is reported for all enrolled participants. Adverse events are reported for all participants who received at least 1 dose of venetoclax.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Phase 1: 600 mg Venetoclax + LDAC

Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

7 / 88 / 86 / 8
Phase 1: 800 mg Venetoclax + LDAC

Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

9 / 1010 / 1010 / 10
Phase 2: 600 mg Venetoclax + LDAC

Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.

68 / 7474 / 7463 / 76

Group identifiers: EG000: Phase 1: 600 mg Venetoclax + LDAC · EG001: Phase 1: 800 mg Venetoclax + LDAC · EG002: Phase 2: 600 mg Venetoclax + 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 (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      2
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      5
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      74
      num Events
      34
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      1
    term
    HAEMOLYTIC ANAEMIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      1
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      1
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      74
      num Events
      0
    term
    ACUTE CORONARY SYNDROME
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      1
    term
    ACUTE MYOCARDIAL INFARCTION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      74
      num Events
      6
    term
    ATRIAL FIBRILLATION
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      1
    term
    ATRIOVENTRICULAR BLOCK FIRST DEGREE
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      2
    term
    BRADYCARDIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      1
    term
    CARDIAC FAILURE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      1
    term
    SINUS BRADYCARDIA

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 (24.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      8
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      74
      num Events
      72
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      74
      num Events
      13
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      74
      num Events
      0
    term
    HYPOFIBRINOGENAEMIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      74
      num Events
      4
    term
    LEUKOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
      num Events
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      5
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      74
      num Events
      25
    term
    NEUTROPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      11
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      74
      num Events
      44
    term
    THROMBOCYTOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      74
      num Events
      2
    term
    ANGINA PECTORIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      74
      num Events
      8
    term
    ATRIAL FIBRILLATION
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      74
      num Events
      3
    term
    BRADYCARDIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      74
      num Events
      2
    term
    CARDIAC FAILURE
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      74
      num Events
      9
    term
    SINUS TACHYCARDIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      74
      num Events
      6
    term
    TACHYCARDIA
Complete source fields
description
All-cause mortality is reported for all enrolled participants. Adverse events are reported for all participants who received at least 1 dose of venetoclax.
event Groups
  1. deaths Num Affected
    6
    deaths Num At Risk
    8
    description
    Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg (Day 2) and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received low-dose cytarabine (LDAC; 20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
    id
    EG000
    other Num Affected
    8
    other Num At Risk
    8
    serious Num Affected
    7
    serious Num At Risk
    8
    title
    Phase 1: 600 mg Venetoclax + LDAC
  2. deaths Num Affected
    10
    deaths Num At Risk
    10
    description
    Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 100 mg (Day 2) and increased up to 800 mg by Day 6. Beginning with Cycle 2, 800 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
    id
    EG001
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    9
    serious Num At Risk
    10
    title
    Phase 1: 800 mg Venetoclax + LDAC
  3. deaths Num Affected
    63
    deaths Num At Risk
    76
    description
    Venetoclax was administered orally once daily (QD) on Days 2 through 28 of Cycle 1. Dosing started at 50 mg, and increased up to 600 mg by Day 6. Beginning with Cycle 2, 600 mg venetoclax was administered Days 1 through 28 of each 28-day cycle. Participants also received LDAC (20 mg/m²) administered by subcutaneous injection once daily on Days 1 to 10 of each cycle. Participants could continue receiving treatment until disease progression or until discontinuation criteria were met.
    id
    EG002
    other Num Affected
    74
    other Num At Risk
    74
    serious Num Affected
    68
    serious Num At Risk
    74
    title
    Phase 2: 600 mg Venetoclax + LDAC
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      8
      num Events
      6
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      74
      num Events
      72
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      12
      num At Risk
      74
      num Events
      13
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      74
      num Events
      0
    term
    HYPOFIBRINOGENAEMIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      2
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      74
      num Events
      4
    term
    LEUKOPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
      num Events
      10
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      5
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      74
      num Events
      25
    term
    NEUTROPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      8
      num Events
      4
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      10
      num Events
      11
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      74
      num Events
      44
    term
    THROMBOCYTOPENIA
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      74
      num Events
      2
    term
    ANGINA PECTORIS
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      74
      num Events
      8
    term
    ATRIAL FIBRILLATION
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      74
      num Events
      3
    term
    BRADYCARDIA
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      74
      num Events
      2
    term
    CARDIAC FAILURE
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      74
      num Events
      9
    term
    SINUS TACHYCARDIA
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      74
      num Events
      6
    term
    TACHYCARDIA
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      10
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      2
    term
    ANAEMIA
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      10
      num Events
      5
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      74
      num Events
      34
    term
    FEBRILE NEUTROPENIA
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      1
    term
    HAEMOLYTIC ANAEMIA
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      1
    term
    NEUTROPENIA
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      1
    term
    THROMBOCYTOPENIA
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      74
      num Events
      0
    term
    ACUTE CORONARY SYNDROME
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      8
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      1
    term
    ACUTE MYOCARDIAL INFARCTION
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      74
      num Events
      6
    term
    ATRIAL FIBRILLATION
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      1
    term
    ATRIOVENTRICULAR BLOCK FIRST DEGREE
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      2
    term
    BRADYCARDIA
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      1
    term
    CARDIAC FAILURE
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (24.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      8
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      10
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      74
      num Events
      1
    term
    SINUS BRADYCARDIA
time Frame
All-cause mortality is reported from enrollment through the end of study; maximum time on study was 63.7 months. Adverse events are reported from first dose of study drug until 30 days after last dose of study drug; median (minimum, maximum) duration of treatment was 4.1 (0.2, 62.8) months overall.

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Preserved source evidence · Not medical advice