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NCT00122460 · ADVERSE EVENTS

Adverse events

Cetuximab (Erbitux) in Combination With Cisplatin or Carboplatin and 5-Fluorouracil in the First Line Treatment of Subjects With Recurrent and/or Metastatic Squamous Cell Carcinoma of the Head and Neck (EXTREME) · Source last updated 2014-07-23

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
Time from first dose up to 30 days after the last dose of study treatment.
Other-event reporting threshold
5%

Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Cetuximab Plus Chemotherapy

Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.

110 / 219214 / 219Not reported / Not reported
Chemotherapy Alone

All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.

102 / 215198 / 215Not reported / Not reported

Group identifiers: EG000: Cetuximab Plus Chemotherapy · EG001: Chemotherapy Alone

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
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      215
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Coagulopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      215
    term
    Febrile bone marrow aplasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      215
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      215
    term
    Haemolysis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      215
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      215
    term
    Leukopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Lymph node pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      215
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      215
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Acute coronary syndrome

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
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      215
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      215
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      215
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      215
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      215
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Conjunctivitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      119
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      215
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      215
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      215
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      215
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      215
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      215
    term
    Dysphagia
Complete source fields
description
Treatment-emergent adverse events were defined as those with onset occurring at or after the first dosing day of study medication and up to 30 days after the last administration of any study drug or the clinical cut-off date.
event Groups
  1. description
    Subjects in will receive initial dose of 400 mg/m\^2 cetuximab (over 2 hours) followed by weekly doses of 250 mg/m\^2 (over 1 hour). All doses will be given by intravenous (IV) infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (Area under the curve (AUC) 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
    id
    EG000
    other Num Affected
    214
    other Num At Risk
    219
    serious Num Affected
    110
    serious Num At Risk
    219
    title
    Cetuximab Plus Chemotherapy
  2. description
    All doses will be given by IV infusion. Subjects will receive either Cisplatin (100 mg/m\^2 on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks or Carboplatin (AUC 5 IV on day 1) + 5-FU (1000 mg/m\^2 continuous IV from day 1 to day 4) every 3 weeks.
    id
    EG001
    other Num Affected
    198
    other Num At Risk
    215
    serious Num Affected
    102
    serious Num At Risk
    215
    title
    Chemotherapy Alone
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      92
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      111
      num At Risk
      215
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      83
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      77
      num At Risk
      215
    term
    Neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      215
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      32
      num At Risk
      215
    term
    Leukopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      215
    term
    Lymphopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Conjunctivitis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      119
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      100
      num At Risk
      215
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      84
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      79
      num At Risk
      215
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      56
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      33
      num At Risk
      215
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      48
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      43
      num At Risk
      215
    term
    Constipation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      31
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      215
    term
    Stomatitis
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      215
    term
    Dysphagia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      215
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Coagulopathy
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      215
    term
    Febrile bone marrow aplasia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      215
    term
    Febrile neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      215
    term
    Haemolysis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      215
    term
    Leukocytosis
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      215
    term
    Leukopenia
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Lymph node pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      215
    term
    Neutropenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Pancytopenia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      215
    term
    Thrombocytopenia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA (10.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      219
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      215
    term
    Acute coronary syndrome
time Frame
Time from first dose up to 30 days after the last dose of study treatment.

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