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NCT02060188 · ADVERSE EVENTS

Adverse events

A Study of Nivolumab Alone or Nivolumab Combination Therapy in Colon Cancer That Has Come Back or Has Spread · Source last updated 2025-11-06

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 Day 1 and up to approximately 127 months.
Other-event reporting threshold
5%

All treated participants

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cohort 1: Nivolumab Monotherapy

Nivolumab 3 mg/kg

46 / 7473 / 7444 / 74
Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg

Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg

72 / 119116 / 11946 / 119
Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W

Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W

22 / 4545 / 4516 / 45
MSS Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg

MSS: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W

8 / 1010 / 109 / 10
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg

Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg

3 / 33 / 33 / 3
Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg

Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg

9 / 1010 / 1010 / 10
Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg

Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg

20 / 3027 / 3029 / 30
Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg

Nivolumab 240 mg + BMS-986016 80 mg

28 / 5048 / 5027 / 50
Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg

Nivolumab FD + Daratumumab 16 mg/kg

29 / 4443 / 4443 / 44

Group identifiers: EG000: Cohort 1: Nivolumab Monotherapy · EG001: Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg · EG002: Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W · EG003: MSS Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg · EG004: Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg · EG005: Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg · EG006: Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg · EG007: Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg · EG008: Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg

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
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Aortic valve stenosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Atrioventricular block first degree
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Cardiac failure congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Cardiogenic shock
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Cardiomyopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Dilated cardiomyopathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Left ventricular dysfunction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    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
    27.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      14
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      6
      num At Risk
      44
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      44
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      44
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Hypoacusis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Vertigo
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      44
    term
    Hypothyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Dry eye
Complete source fields
description
All treated participants
event Groups
  1. deaths Num Affected
    44
    deaths Num At Risk
    74
    description
    Nivolumab 3 mg/kg
    id
    EG000
    other Num Affected
    73
    other Num At Risk
    74
    serious Num Affected
    46
    serious Num At Risk
    74
    title
    Cohort 1: Nivolumab Monotherapy
  2. deaths Num Affected
    46
    deaths Num At Risk
    119
    description
    Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
    id
    EG001
    other Num Affected
    116
    other Num At Risk
    119
    serious Num Affected
    72
    serious Num At Risk
    119
    title
    Cohort 2: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
  3. deaths Num Affected
    16
    deaths Num At Risk
    45
    description
    Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg twice in six weeks Q6W
    id
    EG002
    other Num Affected
    45
    other Num At Risk
    45
    serious Num Affected
    22
    serious Num At Risk
    45
    title
    Cohort 3: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
  4. deaths Num Affected
    9
    deaths Num At Risk
    10
    description
    MSS: Nivolumab 3 mg/kg Q2W with Ipilimumab 1 mg/kg Q6W
    id
    EG003
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    8
    serious Num At Risk
    10
    title
    MSS Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg
  5. deaths Num Affected
    3
    deaths Num At Risk
    3
    description
    Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
    id
    EG004
    other Num Affected
    3
    other Num At Risk
    3
    serious Num Affected
    3
    serious Num At Risk
    3
    title
    Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 1 mg/kg
  6. deaths Num Affected
    10
    deaths Num At Risk
    10
    description
    Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
    id
    EG005
    other Num Affected
    10
    other Num At Risk
    10
    serious Num Affected
    9
    serious Num At Risk
    10
    title
    Non-MSI-H: Nivolumab 1 mg/kg + Ipilimumab 3 mg/kg
  7. deaths Num Affected
    29
    deaths Num At Risk
    30
    description
    Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
    id
    EG006
    other Num Affected
    27
    other Num At Risk
    30
    serious Num Affected
    20
    serious Num At Risk
    30
    title
    Cohort 4: Nivolumab 3 mg/kg + Ipilimumab 1 mg/kg + Cobimetinib 60 mg
  8. deaths Num Affected
    27
    deaths Num At Risk
    50
    description
    Nivolumab 240 mg + BMS-986016 80 mg
    id
    EG007
    other Num Affected
    48
    other Num At Risk
    50
    serious Num Affected
    28
    serious Num At Risk
    50
    title
    Cohort 5: Nivolumab 240 mg + BMS-986016 80 mg
  9. deaths Num Affected
    43
    deaths Num At Risk
    44
    description
    Nivolumab FD + Daratumumab 16 mg/kg
    id
    EG008
    other Num Affected
    43
    other Num At Risk
    44
    serious Num Affected
    29
    serious Num At Risk
    44
    title
    Cohort 6: Nivolumab FD + Daratumumab 16 mg/kg
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      4
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      14
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      9
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      6
      num At Risk
      44
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      1
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      44
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Palpitations
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      1
      num At Risk
      44
    term
    Sinus tachycardia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Hypoacusis
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Vertigo
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      1
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Adrenal insufficiency
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      1
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Hyperthyroidism
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      10
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      8
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      2
      num At Risk
      44
    term
    Hypothyroidism
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      1
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Dry eye
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      3
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Aortic valve stenosis
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Atrial fibrillation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Atrioventricular block first degree
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Cardiac failure congestive
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Cardiogenic shock
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Cardiomyopathy
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Dilated cardiomyopathy
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      0
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Left ventricular dysfunction
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      74
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      119
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      45
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      10
    5. group Id
      EG004
      num Affected
      0
      num At Risk
      3
    6. group Id
      EG005
      num Affected
      0
      num At Risk
      10
    7. group Id
      EG006
      num Affected
      0
      num At Risk
      30
    8. group Id
      EG007
      num Affected
      2
      num At Risk
      50
    9. group Id
      EG008
      num Affected
      0
      num At Risk
      44
    term
    Myocardial infarction
time Frame
From Day 1 and up to approximately 127 months.

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

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