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NCT01032200 · ADVERSE EVENTS

Adverse events

Armodafinil in Treating Fatigue Caused By Radiation Therapy in Patients With Primary Brain Tumors · Source last updated 2021-09-28

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
3 months
Other-event reporting threshold
5%

The denominator for adverse events in each arm is the number of participants who provided post-treatment data.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Arm I - Armodafinil

Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. Armodafinil: Given orally

10 / 2626 / 261 / 26
Arm II - Placebo

Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. placebo: Given orally

8 / 2727 / 272 / 28

Group identifiers: EG000: Arm I - Armodafinil · EG001: Arm II - 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
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Acute Coronary Syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      2
    term
    Agitation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Alanine Aminotransferase Increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      2
    term
    Anxiety
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Chest Pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Confusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Death NOS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Delirium
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      2
    term
    Depression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Dizziness

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
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      26
      num Events
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      27
      num Events
      15
    term
    Alopecia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      26
      num Events
      55
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      27
      num Events
      39
    term
    Anxiety
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
      num Events
      6
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      27
      num Events
      18
    term
    Arthralgia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      27
      num Events
      7
    term
    Back Pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      26
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      3
    term
    Blurred Vision
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      10
    term
    Cognitive Disturbance
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
      num Events
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Confusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      26
      num Events
      6
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      27
      num Events
      7
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      3
    term
    Cough
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      4
    term
    Dermatitis Radiation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      27
      num Events
      4
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      26
      num Events
      24
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      27
      num Events
      32
    term
    Dizziness
Complete source fields
description
The denominator for adverse events in each arm is the number of participants who provided post-treatment data.
event Groups
  1. deaths Num Affected
    1
    deaths Num At Risk
    26
    description
    Patients receive oral armodafinil once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. Armodafinil: Given orally
    id
    EG000
    other Num Affected
    26
    other Num At Risk
    26
    serious Num Affected
    10
    serious Num At Risk
    26
    title
    Arm I - Armodafinil
  2. deaths Num Affected
    2
    deaths Num At Risk
    28
    description
    Patients receive oral placebo once daily beginning no later than the fifth fraction of brain radiotherapy and continuing for 9-11 weeks in the absence of unacceptable toxicity. placebo: Given orally
    id
    EG001
    other Num Affected
    27
    other Num At Risk
    27
    serious Num Affected
    8
    serious Num At Risk
    27
    title
    Arm II - Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      26
      num Events
      11
    2. group Id
      EG001
      num Affected
      6
      num At Risk
      27
      num Events
      15
    term
    Alopecia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      26
      num Events
      55
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      27
      num Events
      39
    term
    Anxiety
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
      num Events
      6
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      27
      num Events
      18
    term
    Arthralgia
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      26
      num Events
      3
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      27
      num Events
      7
    term
    Back Pain
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      26
      num Events
      11
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      3
    term
    Blurred Vision
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      10
    term
    Cognitive Disturbance
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      26
      num Events
      21
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Confusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      26
      num Events
      6
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      27
      num Events
      7
    term
    Constipation
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      3
    term
    Cough
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      4
    term
    Dermatitis Radiation
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      27
      num Events
      4
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      26
      num Events
      24
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      27
      num Events
      32
    term
    Dizziness
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Acute Coronary Syndrome
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      27
      num Events
      2
    term
    Agitation
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Alanine Aminotransferase Increased
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Anemia
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      2
    term
    Anxiety
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Chest Pain
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Confusion
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Death NOS
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      1
    term
    Delirium
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      26
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      27
      num Events
      2
    term
    Depression
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Diarrhea
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      26
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      27
      num Events
      0
    term
    Dizziness
time Frame
3 months

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