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NCT02231749 · ADVERSE EVENTS

Adverse events

Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214) · Source last updated 2026-05-27

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 the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).
Other-event reporting threshold
5%

The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.

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

Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends

367 / 547534 / 547367 / 550
Sunitinib

Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks

277 / 535523 / 535417 / 546
Sunitinib Crossover

Participants received Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240 mg flat dose IV every 2 weeks

6 / 2525 / 2511 / 25

Group identifiers: EG000: Nivolumab + Ipilimumab · EG001: Sunitinib · EG002: Sunitinib Crossover

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
      7
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    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
      547
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Aplastic anaemia
  3. 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
      547
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Autoimmune neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Febrile neutropenia
  5. 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
      547
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Immune thrombocytopenia
  6. 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
      547
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Iron deficiency anaemia
  7. 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
      547
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Neutropenia
  8. 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
      547
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Pancytopenia
  9. 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
      547
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Splenic lesion
  10. 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
      547
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Thrombocytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Acute coronary syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Acute 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
      91
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      116
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      25
    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
      4
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      25
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      25
    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
      16
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      101
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Adrenal insufficiency
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      107
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      155
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      25
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      25
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      25
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      25
    term
    Constipation
Complete source fields
description
The number at risk for all-cause mortality represents all randomized participants. Serious adverse events and other (not including serious) adverse events represent all participants that received at least 1 dose of study medication.
event Groups
  1. deaths Num Affected
    367
    deaths Num At Risk
    550
    description
    Nivolumab 3 mg/kg combined with Ipilimumab 1 mg/kg solutions intravenously every 3 weeks for 4 doses then Nivolumab 3 mg/kg solutions intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends
    id
    EG000
    other Num Affected
    534
    other Num At Risk
    547
    serious Num Affected
    367
    serious Num At Risk
    547
    title
    Nivolumab + Ipilimumab
  2. deaths Num Affected
    417
    deaths Num At Risk
    546
    description
    Sunitinib 50 mg capsules by mouth once daily for 4 weeks then 2 weeks off, continuously until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends After completion of final analysis eligible participants may switch from receiving Sunitinib to receiving Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240mg flat dose IV every 2 weeks
    id
    EG001
    other Num Affected
    523
    other Num At Risk
    535
    serious Num Affected
    277
    serious Num At Risk
    535
    title
    Sunitinib
  3. deaths Num Affected
    11
    deaths Num At Risk
    25
    description
    Participants received Nivolumab 3 mg/kg IV combined with Ipilimumab 1 mg/kg IV every 3 weeks for 4 doses then Nivolumab 240 mg flat dose IV every 2 weeks
    id
    EG002
    other Num Affected
    25
    other Num At Risk
    25
    serious Num Affected
    6
    serious Num At Risk
    25
    title
    Sunitinib Crossover
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
      91
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      116
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      25
    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
      4
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      25
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      75
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      5
      num At Risk
      25
    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
      16
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      101
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Adrenal insufficiency
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      64
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
    term
    Hyperthyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      107
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      155
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      25
    term
    Hypothyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Vision blurred
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      25
    term
    Abdominal distension
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      79
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      92
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      25
    term
    Abdominal pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      25
    term
    Abdominal pain upper
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      106
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      25
    term
    Constipation
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
      7
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    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
      547
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Aplastic anaemia
  3. 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
      547
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Autoimmune neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Febrile neutropenia
  5. 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
      547
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Immune thrombocytopenia
  6. 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
      547
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Iron deficiency anaemia
  7. 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
      547
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Neutropenia
  8. 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
      547
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Pancytopenia
  9. 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
      547
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Splenic lesion
  10. 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
      547
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Thrombocytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Acute coronary syndrome
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      547
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      535
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      25
    term
    Acute myocardial infarction
time Frame
Participants were assessed for all-cause mortality from the date of their randomization until study completion (assessed up to approximately 125 months and 6 days). SAEs and Other AEs were assessed from first dose of study treatment through 100 days following last dose of study treatment (assessed up to approximately 125 months and 6 days).

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