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NCT00492089 · ADVERSE EVENTS

Adverse events

Bevacizumab in Reducing CNS Side Effects in Patients Who Have Undergone Radiation Therapy to the Brain for Primary Brain Tumor, Meningioma, or Head and Neck Cancer · Source last updated 2014-05-09

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
2 years and 9 months
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Bevacizumab

Bevacizumab 7.5 mg/m\^2 intravenous (IV) every 3 weeks

4 / 115 / 11Not reported / Not reported
Placebo

First Intervention Placebo IV (only) every 3 weeks for two courses

0 / 60 / 6Not reported / Not reported

Group identifiers: EG000: Bevacizumab · EG001: Placebo

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
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thrombosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Dysphagia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Seizure

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
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      11
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypertension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      11
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Elevated alanine aminotransferase (ALT)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thrombocytopenia
Complete source fields
event Groups
  1. description
    Bevacizumab 7.5 mg/m\^2 intravenous (IV) every 3 weeks
    id
    EG000
    other Num Affected
    5
    other Num At Risk
    11
    serious Num Affected
    4
    serious Num At Risk
    11
    title
    Bevacizumab
  2. description
    First Intervention Placebo IV (only) every 3 weeks for two courses
    id
    EG001
    other Num Affected
    0
    other Num At Risk
    6
    serious Num Affected
    0
    serious Num At Risk
    6
    title
    Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      11
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Hypertension
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      11
      num Events
      3
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Fatigue
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Elevated alanine aminotransferase (ALT)
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Nausea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thrombocytopenia
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Vascular disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      11
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Thrombosis
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Dysphagia
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      11
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      6
      num Events
      0
    term
    Seizure
time Frame
2 years and 9 months

Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

Preserved source evidence · Not medical advice