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NCT00313729 · ADVERSE EVENTS

Adverse events

Temozolomide in Treating Patients With Low-Grade Glioma · Source last updated 2019-02-07

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
0%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Temozolomide

Temozolomide temozolomide: Chemotherapy

17 / 12031 / 120Not reported / Not reported

Group identifiers: EG000: Temozolomide

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
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Neutrophils/granulocytes (ANC)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Thrombocytopenia (platelets)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Infection with unknown ANC
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
      num Events
      6
    term
    seizure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      120
      num Events
      3
    term
    Headache
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      120
      num Events
      2
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade III
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Hydrocephalus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade III
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Death within 30 days of study drug - unlikely related to study drug
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Death

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
    notes
    Constitutional Symptoms: Fatigue (asthenia, lethargy, malaise)
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      120
      num Events
      18
    term
    Fatigue
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      120
      num Events
      17
    term
    Nausea
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      120
      num Events
      6
    term
    SGPT (ALT) (serum glutamic pyruvic transaminase)
  4. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    AST, SGOT (serum glutamic oxaloacetic transaminase)
  5. notes
    Neurology
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      120
      num Events
      8
    term
    Seizures
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      120
      num Events
      5
    term
    Alkaline phosphatase
  7. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Tremor
  8. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      120
      num Events
      2
    term
    Weight loss
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      120
      num Events
      3
    term
    Anorexia
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      120
      num Events
      10
    term
    Constipation
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      120
      num Events
      5
    term
    Vomiting
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      120
      num Events
      11
    term
    Lymphopenia
Complete source fields
event Groups
  1. description
    Temozolomide temozolomide: Chemotherapy
    id
    EG000
    other Num Affected
    31
    other Num At Risk
    120
    serious Num Affected
    17
    serious Num At Risk
    120
    title
    Temozolomide
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Constitutional Symptoms: Fatigue (asthenia, lethargy, malaise)
    organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      120
      num Events
      18
    term
    Fatigue
  2. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      11
      num At Risk
      120
      num Events
      17
    term
    Nausea
  3. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      120
      num Events
      6
    term
    SGPT (ALT) (serum glutamic pyruvic transaminase)
  4. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    AST, SGOT (serum glutamic oxaloacetic transaminase)
  5. notes
    Neurology
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      120
      num Events
      8
    term
    Seizures
  6. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      120
      num Events
      5
    term
    Alkaline phosphatase
  7. organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Tremor
  8. organ System
    Metabolism and nutrition disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      120
      num Events
      2
    term
    Weight loss
  9. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      120
      num Events
      3
    term
    Anorexia
  10. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      8
      num At Risk
      120
      num Events
      10
    term
    Constipation
  11. organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      120
      num Events
      5
    term
    Vomiting
  12. organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      120
      num Events
      11
    term
    Lymphopenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Neutrophils/granulocytes (ANC)
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade 4
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Thrombocytopenia (platelets)
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Infection with unknown ANC
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      120
      num Events
      6
    term
    seizure
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      120
      num Events
      3
    term
    Headache
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      120
      num Events
      2
    term
    Neutropenia
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade III
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Hydrocephalus
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Grade III
    organ System
    Gastrointestinal disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Vomiting
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    notes
    Death within 30 days of study drug - unlikely related to study drug
    organ System
    Nervous system disorders
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      120
      num Events
      1
    term
    Death

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Preserved source evidence · Not medical advice