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NCT00520936 · ADVERSE EVENTS

Adverse events

A Study of Pemetrexed in Children With Recurrent Cancer · Source last updated 2011-02-25

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
1%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pemetrexed

Pemetrexed 1910 mg/m2 (or 60 mg/kg if patient \<12 months old)

21 / 7210 / 72Not 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 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      72
      num Events
      4
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Hemoglobin
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    Infection
  4. 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
      72
      num Events
      4
    term
    Infection with normal ANC or Grade 1
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Leukocytes
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Lymphopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Neutrophils/granulocytes
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    Platelets
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Pain: Tumor pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Ulceration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    Vomiting

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
      2
      num At Risk
      72
      num Events
      2
    term
    Infection with normal ANC or Grade 1
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Dermatology/Skin - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Pulmonary/Upper Respiratory - Other
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Thrombosis/thrombus/embolism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Sodium, serum-low
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Hemorrhage, GI: Rectum
  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
      72
      num Events
      1
    term
    Pain: Tumor pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    Seizure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Hemorrhage, GU: Urinary NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Renal failure
Complete source fields
event Groups
  1. description
    Pemetrexed 1910 mg/m2 (or 60 mg/kg if patient \<12 months old)
    id
    EG000
    other Num Affected
    10
    other Num At Risk
    72
    serious Num Affected
    21
    serious Num At Risk
    72
    title
    Pemetrexed
frequency Threshold
1
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
      2
      num At Risk
      72
      num Events
      2
    term
    Infection with normal ANC or Grade 1
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Dermatology/Skin - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Pulmonary/Upper Respiratory - Other
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Thrombosis/thrombus/embolism
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Congenital, familial and genetic disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Sodium, serum-low
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Hemorrhage, GI: Rectum
  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
      72
      num Events
      1
    term
    Pain: Tumor pain
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    Seizure
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Hemorrhage, GU: Urinary NOS
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Renal failure
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      72
      num Events
      4
    term
    Febrile neutropenia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Hemoglobin
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    Infection
  4. 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
      72
      num Events
      4
    term
    Infection with normal ANC or Grade 1
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Leukocytes
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Lymphopenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      72
      num Events
      3
    term
    Neutrophils/granulocytes
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    Platelets
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    Nausea
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 12.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Pain: Tumor pain
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 11.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      72
      num Events
      1
    term
    Ulceration
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 13.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      72
      num Events
      2
    term
    Vomiting

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