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NCT01057589 · ADVERSE EVENTS

Adverse events

A Study for Patients With Recurrent or Metastatic Squamous Cell Head and Neck Cancer · Source last updated 2013-09-18

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
Not reported
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pemetrexed Cisplatin Cetuximab

Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.

45 / 6665 / 66Not reported / Not reported

Group identifiers: EG000: Pemetrexed Cisplatin Cetuximab

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 12.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
      num Events
      7
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      66
      num Events
      3
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      66
      num Events
      6
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      66
      num Events
      5
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Cardio-respiratory arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Fanconi syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
      num Events
      5
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
      num Events
      2
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Large intestine perforation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Nausea

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 12.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      66
      num Events
      30
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      66
      num Events
      36
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      66
      num Events
      35
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      66
      num Events
      19
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      66
      num Events
      7
    term
    Conjunctivitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
      num Events
      5
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
      num Events
      6
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      66
      num Events
      7
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      66
      num Events
      29
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      66
      num Events
      28
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      66
      num Events
      11
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      66
      num Events
      13
    term
    Dysphagia
Complete source fields
event Groups
  1. description
    Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
    id
    EG000
    other Num Affected
    65
    other Num At Risk
    66
    serious Num Affected
    45
    serious Num At Risk
    66
    title
    Pemetrexed Cisplatin Cetuximab
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      66
      num Events
      30
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      66
      num Events
      36
    term
    Leukopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      66
      num Events
      35
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      66
      num Events
      19
    term
    Thrombocytopenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      66
      num Events
      7
    term
    Conjunctivitis
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
      num Events
      5
    term
    Lacrimation increased
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
      num Events
      6
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      66
      num Events
      7
    term
    Abdominal pain upper
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      25
      num At Risk
      66
      num Events
      29
    term
    Constipation
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      20
      num At Risk
      66
      num Events
      28
    term
    Diarrhoea
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      66
      num Events
      11
    term
    Dyspepsia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      66
      num Events
      13
    term
    Dysphagia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
      num Events
      7
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      66
      num Events
      3
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      66
      num Events
      6
    term
    Leukopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      66
      num Events
      5
    term
    Neutropenia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Thrombocytopenia
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Cardio-respiratory arrest
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Fanconi syndrome
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      66
      num Events
      5
    term
    Diarrhoea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      66
      num Events
      2
    term
    Dysphagia
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Large intestine perforation
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      66
      num Events
      1
    term
    Nausea

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