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NCT00884741 · ADVERSE EVENTS

Adverse events

Temozolomide and Radiation Therapy With or Without Bevacizumab in Treating Patients With Newly Diagnosed Glioblastoma · Source last updated 2019-07-24

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%

Data is reported for eligible randomized patients with adverse event data who started study treatment. Subjects experiencing more than one of a given serious adverse event (SAE) were counted only once for that SAE. The same methodology was applied for non-serious adverse events.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pre-Randomization TMZ+RT

Temozolomide pre-randomization, radiation therapy pre-randomization. Note that for the purpose of this table, this arm only includes patients that did not continue to randomization.

5 / 107 / 10Not reported / Not reported
Randomized Arm 1: TMZ+RT + Placebo

Temozolomide post-randomization,Radiation therapy post-randomization, placebo

115 / 300292 / 300Not reported / Not reported
Randomized Arm 2: TMZ+RT + Bevacizumab

Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab

141 / 303292 / 303Not reported / Not reported

Group identifiers: EG000: Pre-Randomization TMZ+RT · EG001: Randomized Arm 1: TMZ+RT + Placebo · EG002: Randomized Arm 2: TMZ+RT + Bevacizumab

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      303
    term
    Blood disorder
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      303
    term
    Bone marrow hypocellular
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      303
    term
    Febrile neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      303
    term
    Hemoglobin decreased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      303
    term
    Hemolysis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      303
    term
    Leukopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      303
    term
    Lymphopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      303
    term
    Arrhythmia supraventricular
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      303
    term
    Atrial fibrillation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      303
    term
    Cardiac disorder
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      303
    term
    Left ventricular failure
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      303
    term
    Myocardial ischemia

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
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      303
    term
    Blood disorder
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      124
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      111
      num At Risk
      303
    term
    Hemoglobin decreased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      98
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      119
      num At Risk
      303
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      96
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      114
      num At Risk
      303
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      303
    term
    Hearing loss
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      303
    term
    Tinnitus
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      303
    term
    Eye disorder
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      303
    term
    Vision blurred
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      303
    term
    Abdominal pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      126
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      141
      num At Risk
      303
    term
    Constipation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      64
      num At Risk
      303
    term
    Diarrhea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      303
    term
    Dry mouth
Complete source fields
description
Data is reported for eligible randomized patients with adverse event data who started study treatment. Subjects experiencing more than one of a given serious adverse event (SAE) were counted only once for that SAE. The same methodology was applied for non-serious adverse events.
event Groups
  1. description
    Temozolomide pre-randomization, radiation therapy pre-randomization. Note that for the purpose of this table, this arm only includes patients that did not continue to randomization.
    id
    EG000
    other Num Affected
    7
    other Num At Risk
    10
    serious Num Affected
    5
    serious Num At Risk
    10
    title
    Pre-Randomization TMZ+RT
  2. description
    Temozolomide post-randomization,Radiation therapy post-randomization, placebo
    id
    EG001
    other Num Affected
    292
    other Num At Risk
    300
    serious Num Affected
    115
    serious Num At Risk
    300
    title
    Randomized Arm 1: TMZ+RT + Placebo
  3. description
    Temozolomide post-randomization, radiation therapy post-randomization, bevacizumab
    id
    EG002
    other Num Affected
    292
    other Num At Risk
    303
    serious Num Affected
    141
    serious Num At Risk
    303
    title
    Randomized Arm 2: TMZ+RT + Bevacizumab
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      20
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      303
    term
    Blood disorder
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      124
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      111
      num At Risk
      303
    term
    Hemoglobin decreased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      98
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      119
      num At Risk
      303
    term
    Leukopenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      96
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      114
      num At Risk
      303
    term
    Lymphopenia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      18
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      303
    term
    Hearing loss
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      20
      num At Risk
      303
    term
    Tinnitus
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      19
      num At Risk
      303
    term
    Eye disorder
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      47
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      47
      num At Risk
      303
    term
    Vision blurred
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      22
      num At Risk
      303
    term
    Abdominal pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      126
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      141
      num At Risk
      303
    term
    Constipation
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      48
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      64
      num At Risk
      303
    term
    Diarrhea
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      15
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      15
      num At Risk
      303
    term
    Dry mouth
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      303
    term
    Blood disorder
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      303
    term
    Bone marrow hypocellular
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      303
    term
    Febrile neutropenia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      9
      num At Risk
      303
    term
    Hemoglobin decreased
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      303
    term
    Hemolysis
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      303
    term
    Leukopenia
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      8
      num At Risk
      303
    term
    Lymphopenia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      303
    term
    Arrhythmia supraventricular
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      303
    term
    Atrial fibrillation
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      303
    term
    Cardiac disorder
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      303
    term
    Left ventricular failure
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (3.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      10
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      300
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      303
    term
    Myocardial ischemia

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice