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NCT02899299 · ADVERSE EVENTS

Adverse events

Study of Nivolumab Combined With Ipilimumab Versus Pemetrexed and Cisplatin or Carboplatin as First Line Therapy in Unresectable Pleural Mesothelioma Patients · Source last updated 2024-05-21

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
Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).
Other-event reporting threshold
5%

The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg

Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W

188 / 300277 / 300251 / 303
Pemetrexed Plus Cisplatin or Carboplatin

Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles

106 / 284264 / 284259 / 302

Group identifiers: EG000: Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg · EG001: Pemetrexed Plus Cisplatin or Carboplatin

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
    26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      284
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      284
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      284
    term
    Haematotoxicity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      284
    term
    Myelosuppression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      284
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      284
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      284
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      284
    term
    Thrombocytopenic purpura
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      284
    term
    Acute coronary syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      284
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      284
    term
    Aortic valve disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      284
    term
    Atrial fibrillation

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
    26.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      118
      num At Risk
      284
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      284
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      284
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      284
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      284
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      284
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      284
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      284
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      284
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      124
      num At Risk
      284
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      284
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      284
    term
    Asthenia
Complete source fields
description
The number at Risk for All-Cause Mortality represents all randomized participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication.
event Groups
  1. deaths Num Affected
    251
    deaths Num At Risk
    303
    description
    Nivolumab 3 mg/kg IV Q2W + Ipilimumab 1 mg/kg IV Q6W
    id
    EG000
    other Num Affected
    277
    other Num At Risk
    300
    serious Num Affected
    188
    serious Num At Risk
    300
    title
    Nivolumab 3mg/kg Plus Ipilimumab 1mg/kg
  2. deaths Num Affected
    259
    deaths Num At Risk
    302
    description
    Pemetrexed 500 mg/m\^2 + Cisplatin 75 mg/m\^2 or Carboplatin 5 AUC up to 6 cycles
    id
    EG001
    other Num Affected
    264
    other Num At Risk
    284
    serious Num Affected
    106
    serious Num At Risk
    284
    title
    Pemetrexed Plus Cisplatin or Carboplatin
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      118
      num At Risk
      284
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      284
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      284
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      284
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      284
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      284
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      284
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      57
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      86
      num At Risk
      284
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      96
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      284
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      76
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      124
      num At Risk
      284
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      55
      num At Risk
      284
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      52
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      58
      num At Risk
      284
    term
    Asthenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      284
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      284
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      284
    term
    Haematotoxicity
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      284
    term
    Myelosuppression
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      284
    term
    Neutropenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      284
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      284
    term
    Thrombocytopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      284
    term
    Thrombocytopenic purpura
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      284
    term
    Acute coronary syndrome
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      284
    term
    Acute myocardial infarction
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      284
    term
    Aortic valve disease
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      300
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      284
    term
    Atrial fibrillation
time Frame
Participants were assessed for all-cause mortality from their first dose to their study completion (up to approximately 76 months.) SAEs and Other AEs were assessed from first dose to 100 days post the last dose of study therapy (up to approximately 29 months).

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