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NCT04008030 · ADVERSE EVENTS

Adverse events

A Study of Nivolumab, Nivolumab Plus Ipilimumab, or Investigator's Choice Chemotherapy for the Treatment of Participants With Deficient Mismatch Repair (dMMR)/Microsatellite Instability High (MSI-H) Metastatic Colorectal Cancer (mCRC) · Source last updated 2026-08-20

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
Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months).
Other-event reporting threshold
5%

The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm A: Nivolumab

Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.

161 / 351311 / 351150 / 353
Arm B: Nivolumab + Ipilimumab

Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.

174 / 352330 / 352103 / 354
Arm C: Chemotherapy

Participants received standard of care chemotherapy

58 / 115114 / 11562 / 132
Crossover: Nivolumab + Ipilimumab

Participants assigned to Arm C that experience documented progression of disease (PD) per RECIST 1.1 by Blinded Independent Central Review (BICR) will have an option to crossover to nivolumab plus ipilimumab therapy (Arm B)

38 / 6052 / 6024 / 60

Group identifiers: EG000: Arm A: Nivolumab · EG001: Arm B: Nivolumab + Ipilimumab · EG002: Arm C: Chemotherapy · EG003: Crossover: Nivolumab + Ipilimumab

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
    27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      60
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Eosinophilia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      60
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Cardiac arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Cardiac failure

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
    27.0
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      60
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      60
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      60
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      60
    term
    Hyperthyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      60
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      60
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      60
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      60
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      119
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      66
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      60
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      60
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      60
    term
    Nausea
Complete source fields
description
The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
event Groups
  1. deaths Num Affected
    150
    deaths Num At Risk
    353
    description
    Nivolumab 240 mg infusion on Day 1 and every two weeks during cycles 1 and 2 for a total of 6 doses. Starting from Cycle 3 Day 1 participants received Nivolumab 480 mg infusion every 4 weeks.
    id
    EG000
    other Num Affected
    311
    other Num At Risk
    351
    serious Num Affected
    161
    serious Num At Risk
    351
    title
    Arm A: Nivolumab
  2. deaths Num Affected
    103
    deaths Num At Risk
    354
    description
    Nivolumab 240 mg infusion followed by Ipilimumab 1 mg/kg IV on Day 1 and every three weeks during cycles 1 and 2 for a total of 4 doses. Starting from Cycle 3 Day 1, participants received Nivolumab 480 mg infusion every 4 weeks.
    id
    EG001
    other Num Affected
    330
    other Num At Risk
    352
    serious Num Affected
    174
    serious Num At Risk
    352
    title
    Arm B: Nivolumab + Ipilimumab
  3. deaths Num Affected
    62
    deaths Num At Risk
    132
    description
    Participants received standard of care chemotherapy
    id
    EG002
    other Num Affected
    114
    other Num At Risk
    115
    serious Num Affected
    58
    serious Num At Risk
    115
    title
    Arm C: Chemotherapy
  4. deaths Num Affected
    24
    deaths Num At Risk
    60
    description
    Participants assigned to Arm C that experience documented progression of disease (PD) per RECIST 1.1 by Blinded Independent Central Review (BICR) will have an option to crossover to nivolumab plus ipilimumab therapy (Arm B)
    id
    EG003
    other Num Affected
    52
    other Num At Risk
    60
    serious Num Affected
    38
    serious Num At Risk
    60
    title
    Crossover: Nivolumab + Ipilimumab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      11
      num At Risk
      60
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      26
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      2
      num At Risk
      60
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      60
    term
    Adrenal insufficiency
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      60
    term
    Hyperthyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      60
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      64
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      31
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      60
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      60
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      57
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      4
      num At Risk
      60
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      119
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      66
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      18
      num At Risk
      60
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      60
    term
    Dry mouth
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      58
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      72
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      55
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      15
      num At Risk
      60
    term
    Nausea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      60
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Eosinophilia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      60
    term
    Acute coronary syndrome
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Acute myocardial infarction
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Cardiac arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      351
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      352
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      115
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      60
    term
    Cardiac failure
time Frame
Participants were assessed for all-cause mortality from their first dose to their primary completion (up to approximately 60 months). SAEs and Other AEs were assessed from first dose up to 100 days post last dose (Up to approximately 60 months).

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

Preserved source evidence · Independent clinical review pending · Not medical advice