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NCT03141177 · ADVERSE EVENTS

Adverse events

A Study of Nivolumab Combined With Cabozantinib Compared to Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma · Source last updated 2026-08-24

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: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Treatment A

Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD

160 / 320316 / 32067 / 320
Treatment B

Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD

28 / 5048 / 5014 / 50
Treatment C

Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle

144 / 320306 / 32099 / 320

Group identifiers: EG000: Treatment A · EG001: Treatment B · EG002: Treatment C

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
    22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      320
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      320
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      320
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      320
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      320
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      320
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      320
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      320
    term
    Atrial tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      320
    term
    Atrioventricular block complete
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      320
    term
    Bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      320
    term
    Cardiac arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      320
    term
    Cardiac failure

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      85
      num At Risk
      320
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      320
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      320
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      62
      num At Risk
      320
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      320
    term
    Hyperthyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      109
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      95
      num At Risk
      320
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      320
    term
    Abdominal distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      320
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      320
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      320
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      320
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      202
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      151
      num At Risk
      320
    term
    Diarrhoea
Complete source fields
event Groups
  1. deaths Num Affected
    67
    deaths Num At Risk
    320
    description
    Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
    id
    EG000
    other Num Affected
    316
    other Num At Risk
    320
    serious Num Affected
    160
    serious Num At Risk
    320
    title
    Treatment A
  2. deaths Num Affected
    14
    deaths Num At Risk
    50
    description
    Nivolumab 3 mg/kg IV Q3W (x4 doses) + Cabozantinib 40 mg PO QD + Ipilimumab 1 mg/kg IV Q3W (x4 doses) Then Nivolumab 240 mg flat dose IV Q2W + Cabozantinib 40 mg PO QD
    id
    EG001
    other Num Affected
    48
    other Num At Risk
    50
    serious Num Affected
    28
    serious Num At Risk
    50
    title
    Treatment B
  3. deaths Num Affected
    99
    deaths Num At Risk
    320
    description
    Sunitinib 50 mg PO QD for 4 weeks, followed by 2 weeks off, per cycle
    id
    EG002
    other Num Affected
    306
    other Num At Risk
    320
    serious Num Affected
    144
    serious Num At Risk
    320
    title
    Treatment C
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      85
      num At Risk
      320
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      24
      num At Risk
      320
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      50
      num At Risk
      320
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      62
      num At Risk
      320
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      320
    term
    Hyperthyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      109
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      95
      num At Risk
      320
    term
    Hypothyroidism
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      320
    term
    Abdominal distension
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      50
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      25
      num At Risk
      320
    term
    Abdominal pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      21
      num At Risk
      320
    term
    Abdominal pain upper
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      320
    term
    Colitis
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      39
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      41
      num At Risk
      320
    term
    Constipation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      202
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      151
      num At Risk
      320
    term
    Diarrhoea
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      320
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      320
    term
    Disseminated intravascular coagulation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      320
    term
    Febrile neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      320
    term
    Pancytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      320
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      320
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      320
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      320
    term
    Atrial tachycardia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      320
    term
    Atrioventricular block complete
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      320
    term
    Bradycardia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      320
    term
    Cardiac arrest
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    22.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      320
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      50
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      320
    term
    Cardiac failure
time Frame
All cause mortality: From first visit to up to 31 months following first visit SAEs and AEs: From first dose to 100 days following last dose (up to 32 months)

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Preserved source evidence · Not medical advice