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NCT02105636 · ADVERSE EVENTS

Adverse events

Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141) · Source last updated 2022-10-05

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
Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 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

Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression

165 / 236210 / 236220 / 240
Investigator Choice

Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice

87 / 111108 / 111119 / 121

Group identifiers: EG000: Nivolumab 3mg/kg · EG001: Investigator Choice

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
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      111
    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
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    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
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    term
    Leukopenia
  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
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Atrioventricular block complete
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      111
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Cardio-respiratory 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
      53
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      111
    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
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      111
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      111
    term
    Tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      111
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      111
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      111
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      111
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      111
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      111
    term
    Gastrooesophageal reflux disease
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
    220
    deaths Num At Risk
    240
    description
    Nivolumab was provided at a dose of 3 milligrams/kilogram (mg/kg) using an intravenous (IV) solution for Injection every 2 weeks until disease progression
    id
    EG000
    other Num Affected
    210
    other Num At Risk
    236
    serious Num Affected
    165
    serious Num At Risk
    236
    title
    Nivolumab 3mg/kg
  2. deaths Num Affected
    119
    deaths Num At Risk
    121
    description
    Participants were provided a dose of Cetuximab intravenous (IV) solution for injection at a dose of 400 milligrams per square meter (mg/m\^2) for the first dose followed that a doses of 250 mg/m\^2 weekly until disease progression OR a Methotrexate intravenous (IV) solution for Injection at a dose of 40 or 60 mg/m\^2 weekly until disease progression OR a Docetaxel intravenous (IV) solution for Injection at a dose of 30 or 40 mg/m\^2 weekly until disease progression. The decision regarding which treatment the participant received was at the discretion of the investigator and referred to as Investigators Choice
    id
    EG001
    other Num Affected
    108
    other Num At Risk
    111
    serious Num Affected
    87
    serious Num At Risk
    111
    title
    Investigator Choice
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
      53
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      111
    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
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      111
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      111
    term
    Tachycardia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      111
    term
    Hypothyroidism
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      111
    term
    Constipation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      47
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      111
    term
    Diarrhoea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      111
    term
    Dry mouth
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      111
    term
    Dyspepsia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      30
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      111
    term
    Dysphagia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      111
    term
    Gastrooesophageal reflux disease
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
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      111
    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
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    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
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    term
    Leukopenia
  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
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Acute myocardial infarction
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    term
    Atrial fibrillation
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      111
    term
    Atrial flutter
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Atrioventricular block complete
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      111
    term
    Cardiac arrest
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Cardiac failure
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    24.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      236
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      111
    term
    Cardio-respiratory arrest
time Frame
Adverse Events and Serious Adverse Events were monitored from first dose to 100 days post last dose (Up to a maximum of approximately 70 months). Participants were assessed for All Cause Mortality from their date of randomization until the study was completed (up to approximately 87 months)

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