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NCT00316225 · ADVERSE EVENTS

Adverse events

Study of Pemetrexed in Mesothelioma and Lung Cancer Patients With Fluid Around the Lungs or Abdomen · Source last updated 2010-07-09

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

Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles

12 / 3128 / 31Not reported / Not reported

Group identifiers: EG000: Pemetrexed

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 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      3
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Respiratory tract infection

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 11.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      31
      num Events
      5
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      3
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      4
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      3
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      31
      num Events
      8
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      31
      num Events
      11
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      4
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      31
      num Events
      11
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Chest pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      31
      num Events
      13
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Influenza like illness
Complete source fields
event Groups
  1. description
    Pemetrexed 500 mg/m2 intravenous (IV) every 21 days for 6 cycles
    id
    EG000
    other Num Affected
    28
    other Num At Risk
    31
    serious Num Affected
    12
    serious Num At Risk
    31
    title
    Pemetrexed
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      31
      num Events
      5
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      3
    term
    Lymphopenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      4
    term
    Neutropenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      3
    term
    Abdominal pain upper
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      31
      num Events
      8
    term
    Constipation
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      31
      num Events
      4
    term
    Diarrhoea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      31
      num Events
      11
    term
    Nausea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      4
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      31
      num Events
      11
    term
    Asthenia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Chest pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      31
      num Events
      13
    term
    Fatigue
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Influenza like illness
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Anaemia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Febrile neutropenia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Thrombocytopenia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      31
      num Events
      3
    term
    Atrial fibrillation
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Cardiac failure
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Pericardial effusion
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Abdominal pain
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      3
    term
    Pyrexia
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Infection
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      31
      num Events
      2
    term
    Pneumonia
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      31
      num Events
      1
    term
    Respiratory tract infection

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