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NCT00343382 · OUTCOME

Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0

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.

Measure
NUMBER
Unit
participants
Interval / dispersion
Not reported
Time frame
End of 6 weeks

What was measured

CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.

Groups in this outcome

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.

Pilocarpine 2 Times Per Day

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

Pilocarpine 4 Times Per Day

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

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Collective Placebo63
Pilocarpine 2 Times Per Day65
Pilocarpine 4 Times Per Day66

Reported measurements

Grade 1 or 2 rigors
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Collective Placebo2Not reportedNot reportedNot reportedNot reported
Pilocarpine 2 Times Per Day14Not reportedNot reportedNot reportedNot reported
Pilocarpine 4 Times Per Day17Not reportedNot reportedNot reportedNot reported
Grade 1 or 2 urinary frequency
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Collective Placebo12Not reportedNot reportedNot reportedNot reported
Pilocarpine 2 Times Per Day21Not reportedNot reportedNot reportedNot reported
Pilocarpine 4 Times Per Day29Not reportedNot reportedNot reportedNot reported
Grade 1 or 2 nausea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Collective Placebo7Not reportedNot reportedNot reportedNot reported
Pilocarpine 2 Times Per Day16Not reportedNot reportedNot reportedNot reported
Pilocarpine 4 Times Per Day20Not reportedNot reportedNot reportedNot reported
Grade 1 or 2 sweating
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Collective Placebo19Not reportedNot reportedNot reportedNot reported
Pilocarpine 2 Times Per Day29Not reportedNot reportedNot reportedNot reported
Pilocarpine 4 Times Per Day33Not reportedNot reportedNot reportedNot reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. group Description
    Comparison of Rigors among arms.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.002
    statistical Method
    Kruskal-Wallis
    tested Non Inferiority
    false
  2. group Description
    Comparison of Urinary Frequency among arms
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.006
    statistical Method
    Kruskal-Wallis
    tested Non Inferiority
    false
  3. group Description
    Comparison of nausea among arms
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.030
    statistical Method
    Kruskal-Wallis
    tested Non Inferiority
    false
  4. group Description
    Comparison of sweating among arms
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.062
    statistical Method
    Kruskal-Wallis
    tested Non Inferiority
    false
Complete source fields
analyses
  1. group Description
    Comparison of Rigors among arms.
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.002
    statistical Method
    Kruskal-Wallis
    tested Non Inferiority
    false
  2. group Description
    Comparison of Urinary Frequency among arms
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.006
    statistical Method
    Kruskal-Wallis
    tested Non Inferiority
    false
  3. group Description
    Comparison of nausea among arms
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.030
    statistical Method
    Kruskal-Wallis
    tested Non Inferiority
    false
  4. group Description
    Comparison of sweating among arms
    group Ids
    1. OG000
    2. OG001
    3. OG002
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    0.062
    statistical Method
    Kruskal-Wallis
    tested Non Inferiority
    false
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        14
      3. group Id
        OG002
        value
        17
    title
    Grade 1 or 2 rigors
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        12
      2. group Id
        OG001
        value
        21
      3. group Id
        OG002
        value
        29
    title
    Grade 1 or 2 urinary frequency
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        16
      3. group Id
        OG002
        value
        20
    title
    Grade 1 or 2 nausea
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        29
      3. group Id
        OG002
        value
        33
    title
    Grade 1 or 2 sweating
denoms
  1. counts
    1. group Id
      OG000
      value
      63
    2. group Id
      OG001
      value
      65
    3. group Id
      OG002
      value
      66
    units
    Participants
description
CTCAE Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.
groups
  1. 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
    OG000
    title
    Collective Placebo
  2. description
    Patients receive 5mg of Pilocarpine 2 times per day for 6 weeks.
    id
    OG001
    title
    Pilocarpine 2 Times Per Day
  3. description
    Patients receive 5mg of Pilocarpine 4 times per day for 6 weeks.
    id
    OG002
    title
    Pilocarpine 4 Times Per Day
param Type
NUMBER
reporting Status
POSTED
time Frame
End of 6 weeks
title
Toxicity as Measured by Common Terminology Criteria for Adverse Events (CTCAE) 3.0
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice