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NCT02475681 · ADVERSE EVENTS

Adverse events

Acalabrutinib, Obinutuzumab and Chlorambucil in Treatment naïve CLL · Source last updated 2026-08-25

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 adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years.
Other-event reporting threshold
5%

Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Obinutuzumab in Combination With Chlorambucil

Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.

37 / 169167 / 16917 / 177
Arm B: Acalabrutinib in Combination With Obinutuzumab

Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.

69 / 178171 / 1789 / 179
Arm C: Acalabrutinib Monotherapy

Acalabrutinib will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib

57 / 179170 / 17911 / 179
Arm A Cross-over: Obinutuzumab+Chlorambucil Crossover to Acalabrutinib Monotherapy

Obinutuzumab + Chlorambucil Crossover to Acalabrutinib 100 mg twice daily monotherapy

6 / 4537 / 452 / 45

Group identifiers: EG000: Arm A: Obinutuzumab in Combination With Chlorambucil · EG001: Arm B: Acalabrutinib in Combination With Obinutuzumab · EG002: Arm C: Acalabrutinib Monotherapy · EG003: Arm A Cross-over: Obinutuzumab+Chlorambucil Crossover to Acalabrutinib Monotherapy

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
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Autoimmune haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Haemolysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Iron deficiency anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Angina unstable
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Atrial flutter

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
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      62
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      45
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      40
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      45
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      45
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    term
    Gastrooesophageal reflux disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      45
    term
    Fatigue
Complete source fields
description
Data presented under All-Cause Mortality table are based on ITT Population (all randomized) as those presented in Participant Flow. Data presented under SAE and AE Tables are based on Safety Population (Subjects received at least one dose of study drug).
event Groups
  1. deaths Num Affected
    17
    deaths Num At Risk
    177
    description
    Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting from cycle1 to cycle 6. Chlorambucil will be orally administered on Days 1 and 15 of Cycles 1 through 6. At investigator discretion, subjects randomized to this treatment arm, who had IRC-confirmed disease progression, were eligible to receive crossover treatment with single-agent acalabrutinib at 100 mg BID until disease progression or unacceptable toxicity.
    id
    EG000
    other Num Affected
    167
    other Num At Risk
    169
    serious Num Affected
    37
    serious Num At Risk
    169
    title
    Arm A: Obinutuzumab in Combination With Chlorambucil
  2. deaths Num Affected
    9
    deaths Num At Risk
    179
    description
    Acalabrutinib (ACP-196) will be orally administered starting on Cycle 1 Day 1. Obinutuzumab IV infusions will be administered over a total of 6 treatment cycles, starting in Cycle 2 Day 1. Daily administration of Acalabrutinib (ACP-196) will continue until disease progression or unacceptable toxicity.
    id
    EG001
    other Num Affected
    171
    other Num At Risk
    178
    serious Num Affected
    69
    serious Num At Risk
    178
    title
    Arm B: Acalabrutinib in Combination With Obinutuzumab
  3. deaths Num Affected
    11
    deaths Num At Risk
    179
    description
    Acalabrutinib will be orally administered on Cycle 1 Day 1 until disease progression or unacceptable toxicity. Acalabrutinib
    id
    EG002
    other Num Affected
    170
    other Num At Risk
    179
    serious Num Affected
    57
    serious Num At Risk
    179
    title
    Arm C: Acalabrutinib Monotherapy
  4. deaths Num Affected
    2
    deaths Num At Risk
    45
    description
    Obinutuzumab + Chlorambucil Crossover to Acalabrutinib 100 mg twice daily monotherapy
    id
    EG003
    other Num Affected
    37
    other Num At Risk
    45
    serious Num Affected
    6
    serious Num At Risk
    45
    title
    Arm A Cross-over: Obinutuzumab+Chlorambucil Crossover to Acalabrutinib Monotherapy
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      56
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      23
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    term
    Thrombocytopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      36
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      69
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      62
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      8
      num At Risk
      45
    term
    Diarrhoea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      53
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      40
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      45
    term
    Nausea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      45
    term
    Constipation
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    term
    Vomiting
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      45
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      14
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      45
    term
    Gastrooesophageal reflux disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      50
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      33
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      45
    term
    Fatigue
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Autoimmune haemolytic anaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Haemolysis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Iron deficiency anaemia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      45
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Angina unstable
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Atrial fibrillation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      169
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      178
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      179
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      45
    term
    Atrial flutter
time Frame
All adverse events were reported from randomization date until 30 days after the last dose of study drug or the start of new anticancer therapy (whichever comes first) up to 61 months. After this period, investigators reported SAEs or other AEs of concern that are believed to be related to prior treatment with study drug up to 5 years.

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Preserved source evidence · Not medical advice