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NCT01844505 · ADVERSE EVENTS

Adverse events

Phase 3 Study of Nivolumab or Nivolumab Plus Ipilimumab Versus Ipilimumab Alone in Previously Untreated Advanced Melanoma (CheckMate 067) · Source last updated 2025-05-21

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months).
Other-event reporting threshold
5%

All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.

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

Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity

187 / 313302 / 313192 / 316
Nivolumab + Ipilimumab

Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity

249 / 313302 / 313173 / 314
Ipilimumab

Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses

205 / 311302 / 311243 / 315

Group identifiers: EG000: Nivolumab · EG001: Nivolumab + Ipilimumab · EG002: 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
      5
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      311
    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
      313
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      311
    term
    Anaemia of chronic disease
  3. 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
      313
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      311
    term
    Bicytopenia
  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
      313
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      311
    term
    Eosinophilia
  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
      313
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      311
    term
    Febrile 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
      313
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      311
    term
    Haemolytic anaemia
  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
      313
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      311
    term
    Heparin-induced thrombocytopenia
  8. 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
      313
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      311
    term
    Lymphadenitis
  9. 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
      313
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      311
    term
    Lymphadenopathy
  10. 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
      313
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      311
    term
    Microcytic anaemia
  11. 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
      313
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      311
    term
    Neutropenia
  12. 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
      313
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      311
    term
    Normocytic anaemia

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
      35
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      311
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      311
    term
    Tachycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      311
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      311
    term
    Hyperthyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      311
    term
    Hypophysitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      311
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      311
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      311
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      311
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      68
      num At Risk
      311
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      311
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      311
    term
    Colitis
Complete source fields
description
All cause mortality data was collected for all the randomized participants and serious and other adverse events were collected for all the treated participants.
event Groups
  1. deaths Num Affected
    192
    deaths Num At Risk
    316
    description
    Nivolumab monotherapy 3 mg/kg intravenous (IV) once every 2 weeks (Q2W) until disease progression or unacceptable toxicity
    id
    EG000
    other Num Affected
    302
    other Num At Risk
    313
    serious Num Affected
    187
    serious Num At Risk
    313
    title
    Nivolumab
  2. deaths Num Affected
    173
    deaths Num At Risk
    314
    description
    Nivolumab 1 mg/kg IV combined with Ipilimumab 3 mg/kg IV once every 3 weeks (Q3W) for 4 doses followed by nivolumab 3 mg/kg IV Q2W until disease progression or unacceptable toxicity
    id
    EG001
    other Num Affected
    302
    other Num At Risk
    313
    serious Num Affected
    249
    serious Num At Risk
    313
    title
    Nivolumab + Ipilimumab
  3. deaths Num Affected
    243
    deaths Num At Risk
    315
    description
    Ipilimumab monotherapy 3 mg/kg IV Q3W for a total of 4 doses
    id
    EG002
    other Num Affected
    302
    other Num At Risk
    311
    serious Num Affected
    205
    serious Num At Risk
    311
    title
    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
      35
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      41
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      43
      num At Risk
      311
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      311
    term
    Tachycardia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      311
    term
    Adrenal insufficiency
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      30
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      311
    term
    Hyperthyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      311
    term
    Hypophysitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      38
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      17
      num At Risk
      311
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      311
    term
    Dry eye
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      311
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      13
      num At Risk
      311
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      62
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      68
      num At Risk
      311
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      311
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      311
    term
    Colitis
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
      5
      num At Risk
      313
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      311
    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
      313
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      311
    term
    Anaemia of chronic disease
  3. 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
      313
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      311
    term
    Bicytopenia
  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
      313
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      311
    term
    Eosinophilia
  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
      313
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      311
    term
    Febrile 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
      313
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      311
    term
    Haemolytic anaemia
  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
      313
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      311
    term
    Heparin-induced thrombocytopenia
  8. 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
      313
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      311
    term
    Lymphadenitis
  9. 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
      313
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      311
    term
    Lymphadenopathy
  10. 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
      313
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      311
    term
    Microcytic anaemia
  11. 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
      313
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      311
    term
    Neutropenia
  12. 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
      313
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      313
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      311
    term
    Normocytic anaemia
time Frame
All cause mortality was collected from date of randomization till death due to any cause (up to approximately 128 months) and Serious and Other Adverse events were collected from first dose till 30 days after last dose (up to approximately 128 months).

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Preserved source evidence · Not medical advice