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NCT00369785 · ADVERSE EVENTS

Adverse events

Donepezil in Treating Patients Who Have Undergone Radiation Therapy for Brain Tumors · Source last updated 2021-10-20

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
24 weeks
Other-event reporting threshold
5%

Analysis includes everyone with post-treatment AE/toxicity data.

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

Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily

12 / 9688 / 96Not reported / Not reported
Arm II - Control

Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day

10 / 9280 / 92Not reported / Not reported

Group identifiers: EG000: Arm I - Donepezil · EG001: Arm II - Control

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
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      1
    term
    Aspiration
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      3
    term
    Auditory/Ear - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      2
    term
    Cognitive Disturbance
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      2
    term
    Confusion
  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
      96
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      92
      num Events
      2
    term
    Death NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      1
    term
    Dental: peridontal disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      2
    term
    Dental: teeth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      1
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      96
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      92
      num Events
      0
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      1
    term
    Headache
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      3
    term
    Hearing
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      1
    term
    Infection

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
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      96
      num Events
      33
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      92
      num Events
      17
    term
    Anorexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      96
      num Events
      64
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      92
      num Events
      73
    term
    Cognitive Disturbance
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      96
      num Events
      6
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      92
      num Events
      11
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      96
      num Events
      29
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      92
      num Events
      13
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      96
      num Events
      5
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      92
      num Events
      13
    term
    Dizziness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      96
      num Events
      105
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      92
      num Events
      122
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      96
      num Events
      70
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      92
      num Events
      73
    term
    Headache
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      96
      num Events
      81
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      92
      num Events
      70
    term
    Insomnia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      96
      num Events
      83
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      92
      num Events
      91
    term
    Memory Impairment
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      96
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      92
      num Events
      11
    term
    Muscle Weakness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      96
      num Events
      58
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      92
      num Events
      48
    term
    Muscle Cramps
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      96
      num Events
      19
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      92
      num Events
      21
    term
    Nausea
Complete source fields
description
Analysis includes everyone with post-treatment AE/toxicity data.
event Groups
  1. description
    Weeks 1-6: One 5 mg tablet orally donepezil hydrochloride Weeks 7-24: Two 5mg tablets per day donepezil hydrochloride: Weeks 1-6: One tablet Donepezil 5 mg given daily Weeks 7-24: Two Donepezil 5 mg tablets given daily
    id
    EG000
    other Num Affected
    88
    other Num At Risk
    96
    serious Num Affected
    12
    serious Num At Risk
    96
    title
    Arm I - Donepezil
  2. description
    Weeks 1-6: One placebo tablet per day Weeks 7-24: Two placebo tablets per day Placebo: Weeks 1-6: One tablet per day Weeks 7-24: Two tablets per day
    id
    EG001
    other Num Affected
    80
    other Num At Risk
    92
    serious Num Affected
    10
    serious Num At Risk
    92
    title
    Arm II - Control
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      21
      num At Risk
      96
      num Events
      33
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      92
      num Events
      17
    term
    Anorexia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      26
      num At Risk
      96
      num Events
      64
    2. group Id
      EG001
      num Affected
      28
      num At Risk
      92
      num Events
      73
    term
    Cognitive Disturbance
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      96
      num Events
      6
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      92
      num Events
      11
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      24
      num At Risk
      96
      num Events
      29
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      92
      num Events
      13
    term
    Diarrhea
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      96
      num Events
      5
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      92
      num Events
      13
    term
    Dizziness
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      55
      num At Risk
      96
      num Events
      105
    2. group Id
      EG001
      num Affected
      61
      num At Risk
      92
      num Events
      122
    term
    Fatigue
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      42
      num At Risk
      96
      num Events
      70
    2. group Id
      EG001
      num Affected
      40
      num At Risk
      92
      num Events
      73
    term
    Headache
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      43
      num At Risk
      96
      num Events
      81
    2. group Id
      EG001
      num Affected
      36
      num At Risk
      92
      num Events
      70
    term
    Insomnia
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      34
      num At Risk
      96
      num Events
      83
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      92
      num Events
      91
    term
    Memory Impairment
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      96
      num Events
      5
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      92
      num Events
      11
    term
    Muscle Weakness
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      32
      num At Risk
      96
      num Events
      58
    2. group Id
      EG001
      num Affected
      26
      num At Risk
      92
      num Events
      48
    term
    Muscle Cramps
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      96
      num Events
      19
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      92
      num Events
      21
    term
    Nausea
serious Events
  1. 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
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      1
    term
    Aspiration
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      3
    term
    Auditory/Ear - Other
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      2
    term
    Cognitive Disturbance
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      2
    term
    Confusion
  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
      96
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      92
      num Events
      2
    term
    Death NOS
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      1
    term
    Dental: peridontal disease
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      2
    term
    Dental: teeth
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      1
    term
    Diarrhea
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      96
      num Events
      5
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      92
      num Events
      0
    term
    Fatigue
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      96
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      1
    term
    Headache
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      3
    term
    Hearing
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      96
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      92
      num Events
      1
    term
    Infection
time Frame
24 weeks

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