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NCT03215706 · ADVERSE EVENTS

Adverse events

A Study of Nivolumab and Ipilimumab Combined With Chemotherapy Compared to Chemotherapy Alone in First Line NSCLC · Source last updated 2025-12-17

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
30 days after last dose, assessed up to October 2024, approximately 72 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
Treatment A

Nivolumab + Ipilimumab + Chemotherapy

259 / 358343 / 358304 / 361
Treatment B

Chemotherapy Only

197 / 349329 / 349318 / 358

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

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
      11
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      349
    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
      358
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      349
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      349
    term
    Febrile neutropenia
  4. 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
      358
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      349
    term
    Neutropenia
  5. 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
      358
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      349
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      349
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      349
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      349
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    term
    Atrioventricular block
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      349
    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
    27.1
    stats
    1. group Id
      EG000
      num Affected
      122
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      161
      num At Risk
      349
    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
      39
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      349
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      349
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      349
    term
    Hyperthyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      349
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      349
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      349
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      85
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      349
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      111
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      349
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      146
      num At Risk
      349
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      349
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      96
      num At Risk
      349
    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
    304
    deaths Num At Risk
    361
    description
    Nivolumab + Ipilimumab + Chemotherapy
    id
    EG000
    other Num Affected
    343
    other Num At Risk
    358
    serious Num Affected
    259
    serious Num At Risk
    358
    title
    Treatment A
  2. deaths Num Affected
    318
    deaths Num At Risk
    358
    description
    Chemotherapy Only
    id
    EG001
    other Num Affected
    329
    other Num At Risk
    349
    serious Num Affected
    197
    serious Num At Risk
    349
    title
    Treatment B
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
      122
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      161
      num At Risk
      349
    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
      39
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      60
      num At Risk
      349
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      38
      num At Risk
      349
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      349
    term
    Hyperthyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      61
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      349
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      349
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      349
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      85
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      83
      num At Risk
      349
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      111
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      68
      num At Risk
      349
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      120
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      146
      num At Risk
      349
    term
    Nausea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      71
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      349
    term
    Vomiting
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      112
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      96
      num At Risk
      349
    term
    Asthenia
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
      11
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      349
    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
      358
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      349
    term
    Febrile bone marrow aplasia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      349
    term
    Febrile neutropenia
  4. 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
      358
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      349
    term
    Neutropenia
  5. 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
      358
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      349
    term
    Pancytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      349
    term
    Thrombocytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      349
    term
    Acute coronary syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    term
    Acute myocardial infarction
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    term
    Angina pectoris
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      349
    term
    Atrial fibrillation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      349
    term
    Atrioventricular block
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    27.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      358
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      349
    term
    Cardiac arrest
time Frame
30 days after last dose, assessed up to October 2024, approximately 72 months

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