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NCT01535040 · ADVERSE EVENTS

Adverse events

Memantine Hydrochloride in Helping Cancer Survivors Stop Smoking · 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
4 months (3 months of treatment and 1 month following the end of treatment)
Other-event reporting threshold
5%

The sample size for this section is the number of participants who had post-randomization toxicity data recorded.

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

Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity. memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks.

5 / 5748 / 57Not reported / Not reported
Arm II - Placebo

Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity. placebo: Placebo by mouth through completion of 12 weeks.

3 / 5951 / 59Not reported / Not reported

Group identifiers: EG000: Arm I - Memantine · 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
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Back Pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Fracture
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      59
      num Events
      7
    term
    Hypertension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Liver Dysfunction / Failure
  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
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Retinal Tear

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
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      57
      num Events
      54
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      59
      num Events
      38
    term
    Back Pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      57
      num Events
      21
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      59
      num Events
      9
    term
    Confusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      57
      num Events
      31
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      59
      num Events
      27
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      57
      num Events
      69
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      59
      num Events
      72
    term
    Cough
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      57
      num Events
      12
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      59
      num Events
      15
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      57
      num Events
      25
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      59
      num Events
      22
    term
    Dizziness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      57
      num Events
      55
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      59
      num Events
      40
    term
    Dyspnea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      57
      num Events
      83
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      59
      num Events
      66
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      57
      num Events
      33
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      59
      num Events
      33
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      57
      num Events
      31
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      59
      num Events
      37
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      59
      num Events
      15
    term
    Renal and Urinary Disorder - Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      57
      num Events
      23
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      59
      num Events
      17
    term
    Somnolence
Complete source fields
description
The sample size for this section is the number of participants who had post-randomization toxicity data recorded.
event Groups
  1. description
    Participants receive memantine hydrochloride PO BID) on days 1-81 in the absence of unacceptable toxicity. memantine hydrochloride: Estimate participation, accrual, adherence, and retention of cancer survivors who smoke and are randomized to receive memantine (10 mg twice daily) or a matching placebo for 12 weeks.
    id
    EG000
    other Num Affected
    48
    other Num At Risk
    57
    serious Num Affected
    5
    serious Num At Risk
    57
    title
    Arm I - Memantine
  2. description
    Participants receive a placebo PO BID on days 1-81 in the absence of unacceptable toxicity. placebo: Placebo by mouth through completion of 12 weeks.
    id
    EG001
    other Num Affected
    51
    other Num At Risk
    59
    serious Num Affected
    3
    serious Num At Risk
    59
    title
    Arm II - Placebo
frequency Threshold
5
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      14
      num At Risk
      57
      num Events
      54
    2. group Id
      EG001
      num Affected
      12
      num At Risk
      59
      num Events
      38
    term
    Back Pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      57
      num Events
      21
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      59
      num Events
      9
    term
    Confusion
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      57
      num Events
      31
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      59
      num Events
      27
    term
    Constipation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      22
      num At Risk
      57
      num Events
      69
    2. group Id
      EG001
      num Affected
      27
      num At Risk
      59
      num Events
      72
    term
    Cough
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      6
      num At Risk
      57
      num Events
      12
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      59
      num Events
      15
    term
    Diarrhea
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Ear and labyrinth disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      57
      num Events
      25
    2. group Id
      EG001
      num Affected
      10
      num At Risk
      59
      num Events
      22
    term
    Dizziness
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      16
      num At Risk
      57
      num Events
      55
    2. group Id
      EG001
      num Affected
      16
      num At Risk
      59
      num Events
      40
    term
    Dyspnea
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      33
      num At Risk
      57
      num Events
      83
    2. group Id
      EG001
      num Affected
      25
      num At Risk
      59
      num Events
      66
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      19
      num At Risk
      57
      num Events
      33
    2. group Id
      EG001
      num Affected
      19
      num At Risk
      59
      num Events
      33
    term
    Headache
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      57
      num Events
      31
    2. group Id
      EG001
      num Affected
      13
      num At Risk
      59
      num Events
      37
    term
    Hypertension
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      59
      num Events
      15
    term
    Renal and Urinary Disorder - Other
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      13
      num At Risk
      57
      num Events
      23
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      59
      num Events
      17
    term
    Somnolence
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      4
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Back Pain
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Fracture
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Cardiac disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      59
      num Events
      7
    term
    Hypertension
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      57
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      59
      num Events
      1
    term
    Liver Dysfunction / Failure
  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
      57
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Pain
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    CTCAE (4.0)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      57
      num Events
      2
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      59
      num Events
      0
    term
    Retinal Tear
time Frame
4 months (3 months of treatment and 1 month following the end of treatment)

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