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NCT00343382 · ADVERSE EVENTS

Adverse events

Pilocarpine in Treating Vaginal Dryness in Patients With Breast Cancer · Source last updated 2016-08-12

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
End of 6 Weeks
Other-event reporting threshold
0%

Adverse event information at end of 6 weeks is not available on one participant from collective placebo arm.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Pilocarpine 2 Times Per Day

Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.

0 / 6548 / 65Not reported / Not reported
Pilocarpine 4 Times Per Day

Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.

0 / 6647 / 66Not reported / Not reported
Collective Placebo

Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.

0 / 6333 / 63Not reported / Not reported

Group identifiers: EG000: Pilocarpine 2 Times Per Day · EG001: Pilocarpine 4 Times Per Day · EG002: Collective Placebo

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    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
      Eye disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        65
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        66
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        63
        num Events
        0
      term
      Flashing vision
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        65
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        66
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        63
        num Events
        0
      term
      Abdominal distension
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        65
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        66
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        63
        num Events
        0
      term
      Diarrhea
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        65
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        66
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        63
        num Events
        1
      term
      Dry mouth
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        65
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        66
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        63
        num Events
        0
      term
      Flatulence
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        65
        num Events
        0
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        66
        num Events
        3
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        63
        num Events
        1
      term
      Gastrointestinal disorder
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        16
        num At Risk
        65
        num Events
        16
      2. group Id
        EG001
        num Affected
        20
        num At Risk
        66
        num Events
        20
      3. group Id
        EG002
        num Affected
        7
        num At Risk
        63
        num Events
        7
      term
      Nausea
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        65
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        66
        num Events
        2
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        63
        num Events
        0
      term
      Salivary gland disorder
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        14
        num At Risk
        65
        num Events
        14
      2. group Id
        EG001
        num Affected
        17
        num At Risk
        66
        num Events
        17
      3. group Id
        EG002
        num Affected
        2
        num At Risk
        63
        num Events
        2
      term
      Rigors
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        65
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        66
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        63
        num Events
        0
      term
      General symptom
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        65
        num Events
        10
      2. group Id
        EG001
        num Affected
        13
        num At Risk
        66
        num Events
        13
      3. group Id
        EG002
        num Affected
        6
        num At Risk
        63
        num Events
        6
      term
      Dizziness
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        65
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        66
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        63
        num Events
        0
      term
      Headache
    Complete source fields
    description
    Adverse event information at end of 6 weeks is not available on one participant from collective placebo arm.
    event Groups
    1. description
      Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
      id
      EG000
      other Num Affected
      48
      other Num At Risk
      65
      serious Num Affected
      0
      serious Num At Risk
      65
      title
      Pilocarpine 2 Times Per Day
    2. description
      Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
      id
      EG001
      other Num Affected
      47
      other Num At Risk
      66
      serious Num Affected
      0
      serious Num At Risk
      66
      title
      Pilocarpine 4 Times Per Day
    3. description
      Patients receive 1 capsule of placebo 2 times per day for 6 weeks and; patients receive 1 capsule of placebo 4 times per day for 6 weeks.
      id
      EG002
      other Num Affected
      33
      other Num At Risk
      63
      serious Num Affected
      0
      serious Num At Risk
      63
      title
      Collective Placebo
    frequency Threshold
    0
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Eye disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        65
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        66
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        63
        num Events
        0
      term
      Flashing vision
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        65
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        66
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        63
        num Events
        0
      term
      Abdominal distension
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        65
        num Events
        0
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        66
        num Events
        1
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        63
        num Events
        0
      term
      Diarrhea
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        65
        num Events
        0
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        66
        num Events
        0
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        63
        num Events
        1
      term
      Dry mouth
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        65
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        66
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        63
        num Events
        0
      term
      Flatulence
    6. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        65
        num Events
        0
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        66
        num Events
        3
      3. group Id
        EG002
        num Affected
        1
        num At Risk
        63
        num Events
        1
      term
      Gastrointestinal disorder
    7. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        16
        num At Risk
        65
        num Events
        16
      2. group Id
        EG001
        num Affected
        20
        num At Risk
        66
        num Events
        20
      3. group Id
        EG002
        num Affected
        7
        num At Risk
        63
        num Events
        7
      term
      Nausea
    8. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Gastrointestinal disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        65
        num Events
        0
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        66
        num Events
        2
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        63
        num Events
        0
      term
      Salivary gland disorder
    9. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        14
        num At Risk
        65
        num Events
        14
      2. group Id
        EG001
        num Affected
        17
        num At Risk
        66
        num Events
        17
      3. group Id
        EG002
        num Affected
        2
        num At Risk
        63
        num Events
        2
      term
      Rigors
    10. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        65
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        66
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        63
        num Events
        0
      term
      General symptom
    11. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        10
        num At Risk
        65
        num Events
        10
      2. group Id
        EG001
        num Affected
        13
        num At Risk
        66
        num Events
        13
      3. group Id
        EG002
        num Affected
        6
        num At Risk
        63
        num Events
        6
      term
      Dizziness
    12. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Nervous system disorders
      source Vocabulary
      CTCAEV3.0
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        65
        num Events
        1
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        66
        num Events
        0
      3. group Id
        EG002
        num Affected
        0
        num At Risk
        63
        num Events
        0
      term
      Headache
    time Frame
    End of 6 Weeks

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

    Preserved source evidence · Not medical advice