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NCT02741570 · ADVERSE EVENTS

Adverse events

Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck · Source last updated 2023-09-21

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
All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 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 + Ipilimumab

Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.

313 / 468420 / 468388 / 472
EXTREME Regimen

Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.

290 / 441429 / 441406 / 475

Group identifiers: EG000: Nivolumab + Ipilimumab · EG001: EXTREME Regimen

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
    25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      441
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      441
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      441
    term
    Cytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      441
    term
    Disseminated intravascular coagulation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      441
    term
    Febrile bone marrow aplasia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      441
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      441
    term
    Iron deficiency anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      441
    term
    Leukopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      441
    term
    Lymphadenopathy mediastinal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      441
    term
    Myelosuppression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      441
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      441
    term
    Pancytopenia

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
    25.0
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      190
      num At Risk
      441
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      441
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      441
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      131
      num At Risk
      441
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      109
      num At Risk
      441
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      441
    term
    Tinnitus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      441
    term
    Hyperthyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      86
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      441
    term
    Hypothyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      441
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      157
      num At Risk
      441
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      104
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      141
      num At Risk
      441
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      441
    term
    Dyspepsia
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
    388
    deaths Num At Risk
    472
    description
    Nivolumab 3 mg/kg IV every 2 weeks + Ipilimumab 1 mg/kg IV every 6 weeks until progression, unacceptable toxicity, or a maximum of 24 months from first nivolumab treatment.
    id
    EG000
    other Num Affected
    420
    other Num At Risk
    468
    serious Num Affected
    313
    serious Num At Risk
    468
    title
    Nivolumab + Ipilimumab
  2. deaths Num Affected
    406
    deaths Num At Risk
    475
    description
    Cetuximab 400 mg/m2 IV for the initial dose only, then 250 mg/m2 weekly + cisplatin (100mg/m2) or carboplatin (AUC of 5 mg per milliliter per minute) on Day 1 and fluorouracil (1000 mg/m2 per day for 4 days) every 3 weeks for maximum of 6 cycles followed by maintenance cetuximab at 250 mg/m2 weekly (or every 2 weeks, per local prescribing information) until disease progression or unacceptable toxicity; the choice of cisplatin or carboplatin is at the discretion of the investigator.
    id
    EG001
    other Num Affected
    429
    other Num At Risk
    441
    serious Num Affected
    290
    serious Num At Risk
    441
    title
    EXTREME Regimen
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      102
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      190
      num At Risk
      441
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      35
      num At Risk
      441
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      17
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      441
    term
    Lymphopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      131
      num At Risk
      441
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      109
      num At Risk
      441
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      441
    term
    Tinnitus
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      40
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      441
    term
    Hyperthyroidism
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Endocrine disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      86
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      441
    term
    Hypothyroidism
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      441
    term
    Abdominal pain
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      95
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      157
      num At Risk
      441
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      104
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      141
      num At Risk
      441
    term
    Diarrhoea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      29
      num At Risk
      441
    term
    Dyspepsia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      441
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      441
    term
    Bone marrow failure
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      441
    term
    Cytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      441
    term
    Disseminated intravascular coagulation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      441
    term
    Febrile bone marrow aplasia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      24
      num At Risk
      441
    term
    Febrile neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      441
    term
    Iron deficiency anaemia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      441
    term
    Leukopenia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      441
    term
    Lymphadenopathy mediastinal
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      441
    term
    Myelosuppression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      441
    term
    Neutropenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    25.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      468
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      441
    term
    Pancytopenia
time Frame
All-cause mortality was assessed from participants first dose to their study completion (up to approximately 65 months). SAEs and Other AEs were assessed from first dose to 100 days following last dose (up to approximately 63 months)

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