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NCT04025879 · ADVERSE EVENTS

Adverse events

A Study of Neoadjuvant Chemotherapy Plus Nivolumab Versus Neoadjuvant Chemotherapy Plus Placebo, Followed by Surgical Removal and Adjuvant Treatment With Nivolumab or Placebo for Participants With Surgically Removable Early Stage Non-small Cell Lung Cancer · Source last updated 2026-08-26

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 randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 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 + SOC Chemotherapy

Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)

109 / 228214 / 22840 / 229
Placebo + SOC Chemotherapy

Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).

83 / 230212 / 23048 / 232

Group identifiers: EG000: Nivolumab + SOC Chemotherapy · EG001: Placebo + SOC Chemotherapy

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
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      230
    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
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Febrile neutropenia
  4. 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
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    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
      228
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      230
    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
      2
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Angina pectoris
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      230
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      230
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Cardiac tamponade

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
      93
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      230
    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
      7
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      230
    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
      23
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      230
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      230
    term
    Hyperthyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      230
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      230
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      230
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      230
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      230
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      230
    term
    Gastrooesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      230
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      230
    term
    Vomiting
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
    40
    deaths Num At Risk
    229
    description
    Nivolumab 360 mg Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery; then post surgery nivolumab 480 mg Q4W adjuvant treatment for up to 13 cycles (approximately 1 year)
    id
    EG000
    other Num Affected
    214
    other Num At Risk
    228
    serious Num Affected
    109
    serious Num At Risk
    228
    title
    Nivolumab + SOC Chemotherapy
  2. deaths Num Affected
    48
    deaths Num At Risk
    232
    description
    Placebo Q3W + SOC platinum-based doublet chemotherapy Q3W x 4 cycles as neoadjuvant treatment followed by surgery, then post-surgery placebo Q4W for up to 13 cycles (approximately 1 year).
    id
    EG001
    other Num Affected
    212
    other Num At Risk
    230
    serious Num Affected
    83
    serious Num At Risk
    230
    title
    Placebo + SOC Chemotherapy
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
      93
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      73
      num At Risk
      230
    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
      7
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      230
    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
      23
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      22
      num At Risk
      230
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      230
    term
    Hyperthyroidism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      28
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      230
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      230
    term
    Abdominal pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      230
    term
    Abdominal pain upper
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      72
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      230
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      37
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      230
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      230
    term
    Gastrooesophageal reflux disease
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      67
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      78
      num At Risk
      230
    term
    Nausea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      230
    term
    Vomiting
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
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      230
    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
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Febrile neutropenia
  4. 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
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    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
      228
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      230
    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
      2
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Pancytopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Acute myocardial infarction
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Angina pectoris
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      230
    term
    Atrial fibrillation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      230
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    26.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      228
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      230
    term
    Cardiac tamponade
time Frame
All-cause mortality was assessed from randomization to primary completion (up to approximately 44 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 30 months)

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