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NCT01668784 · ADVERSE EVENTS

Adverse events

Study of Nivolumab (BMS-936558) vs. Everolimus in Pre-Treated Advanced or Metastatic Clear-cell Renal Cell Carcinoma (CheckMate 025) · Source last updated 2022-08-09

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 assessed from first dose to study completion (up to 105 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (approximately up to 107 months)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
NIVOLUMAB

Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.

248 / 406392 / 406324 / 406
EVEROLIMUS

Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.

243 / 397379 / 397342 / 397

Group identifiers: EG000: NIVOLUMAB · EG001: EVEROLIMUS

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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      397
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      397
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      397
    term
    Methaemoglobinaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      397
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      397
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      397
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      397
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      397
    term
    Arrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      397
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      397
    term
    Atrial flutter
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      397
    term
    Atrioventricular block
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      397
    term
    Cardiac arrest

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
    24.0
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      149
      num At Risk
      397
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      397
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      397
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      397
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      110
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      93
      num At Risk
      397
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      141
      num At Risk
      397
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      397
    term
    Dry mouth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      397
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      139
      num At Risk
      397
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      125
      num At Risk
      397
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      77
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      80
      num At Risk
      397
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      397
    term
    Asthenia
Complete source fields
event Groups
  1. deaths Num Affected
    324
    deaths Num At Risk
    406
    description
    Nivolumab at 3 mg/kg solution provided intravenously every 2 weeks until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    id
    EG000
    other Num Affected
    392
    other Num At Risk
    406
    serious Num Affected
    248
    serious Num At Risk
    406
    title
    NIVOLUMAB
  2. deaths Num Affected
    342
    deaths Num At Risk
    397
    description
    Everolimus provided in 10 mg tablets by mouth daily until documented disease progression, discontinuation due to toxicity, withdrawal of consent or the study ends.
    id
    EG001
    other Num Affected
    379
    other Num At Risk
    397
    serious Num Affected
    243
    serious Num At Risk
    397
    title
    EVEROLIMUS
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      93
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      149
      num At Risk
      397
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      397
    term
    Hypothyroidism
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      397
    term
    Abdominal pain
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      397
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      110
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      93
      num At Risk
      397
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      141
      num At Risk
      397
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      397
    term
    Dry mouth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      397
    term
    Dyspepsia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      135
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      139
      num At Risk
      397
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      29
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      125
      num At Risk
      397
    term
    Stomatitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      77
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      80
      num At Risk
      397
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      44
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      71
      num At Risk
      397
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      397
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      397
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      397
    term
    Methaemoglobinaemia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      397
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      397
    term
    Acute coronary syndrome
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      397
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      397
    term
    Angina pectoris
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      397
    term
    Arrhythmia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      397
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      397
    term
    Atrial flutter
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      397
    term
    Atrioventricular block
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      406
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      397
    term
    Cardiac arrest
time Frame
All-cause mortality was assessed from first dose to study completion (up to 105 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (approximately up to 107 months)

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