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NCT00503997 · ADVERSE EVENTS

Adverse events

Pemetrexed and Oxaliplatin in Treating Patients With Locally Advanced Head and Neck Cancer · Source last updated 2012-05-10

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/Oxaliplatin

Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.

7 / 4211 / 42Not reported / Not reported

Group identifiers: EG000: Pemetrexed/Oxaliplatin

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Diarrhea
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Esophagus pain
  3. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    ANC/AGC
  4. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    hearing loss, sudden
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    infection, port-a-cath
  6. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    DVT/PE
  7. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    myelosupression
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    pneumonia
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    acidosis
  10. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    febrile neutropenia
  11. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    dehydration
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    sepsis

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      42
      num Events
      7
    term
    hypokalemia
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      42
      num Events
      4
    term
    diarrhea
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      42
      num Events
      7
    term
    neutropenia
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    dehydration
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    infection
Complete source fields
event Groups
  1. description
    Patients receive pemetrexed disodium IV and oxaliplatin IV over 2 hours on day 1. Treatment repeats every 14 days for up to 4 courses. If patient progresses before receiving 4 courses of treatment, treatment will be discontinued and patient will proceed to surgery.
    id
    EG000
    other Num Affected
    11
    other Num At Risk
    42
    serious Num Affected
    7
    serious Num At Risk
    42
    title
    Pemetrexed/Oxaliplatin
frequency Threshold
5
other Events
  1. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      42
      num Events
      7
    term
    hypokalemia
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      42
      num Events
      4
    term
    diarrhea
  3. organ System
    General disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      42
      num Events
      7
    term
    neutropenia
  4. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    dehydration
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      42
      num Events
      2
    term
    infection
serious Events
  1. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Diarrhea
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    Esophagus pain
  3. organ System
    Investigations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    ANC/AGC
  4. organ System
    Ear and labyrinth disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    hearing loss, sudden
  5. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    infection, port-a-cath
  6. organ System
    Vascular disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    DVT/PE
  7. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    myelosupression
  8. organ System
    Respiratory, thoracic and mediastinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    pneumonia
  9. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    acidosis
  10. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    febrile neutropenia
  11. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    dehydration
  12. organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      42
      num Events
      1
    term
    sepsis

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Preserved source evidence · Not medical advice