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NCT00719563 · OUTCOME

Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence

American Ginseng in Treating Patients With Fatigue Caused by Cancer · Source last updated 2017-02-09

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
Week 1 to Week 8

What was measured

Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.

Analysis population: Includes all participants that reported at least one value after baseline.

Groups in this outcome

Ginseng

Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.

Placebo

Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment..

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

Analysis denominator · Participants

GroupSource count
Ginseng168
Placebo169

Reported measurements

Grade 2 Nausea
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ginseng5Not reportedNot reportedNot reportedNot reported
Placebo3Not reportedNot reportedNot reportedNot reported
Grade 2 Vomiting
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ginseng2Not reportedNot reportedNot reportedNot reported
Placebo2Not reportedNot reportedNot reportedNot reported
Grade 2 Insomnia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ginseng9Not reportedNot reportedNot reportedNot reported
Placebo10Not reportedNot reportedNot reportedNot reported
Grade 3 Insomnia
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ginseng1Not reportedNot reportedNot reportedNot reported
Placebo1Not reportedNot reportedNot reportedNot reported
Grade 2 Anxiety
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ginseng4Not reportedNot reportedNot reportedNot reported
Placebo5Not reportedNot reportedNot reportedNot reported
Grade 2 Agitation
Values in participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Ginseng2Not reportedNot reportedNot reportedNot reported
Placebo4Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        5
      2. group Id
        OG001
        value
        3
    title
    Grade 2 Nausea
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        2
    title
    Grade 2 Vomiting
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        9
      2. group Id
        OG001
        value
        10
    title
    Grade 2 Insomnia
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
    title
    Grade 3 Insomnia
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        5
    title
    Grade 2 Anxiety
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
    title
    Grade 2 Agitation
denoms
  1. counts
    1. group Id
      OG000
      value
      168
    2. group Id
      OG001
      value
      169
    units
    Participants
description
Adverse events were assessed by Common Terminology Criteria for Adverse Events (CTCAE) v3.0. Grading: Grade 1=Mild, Grade 2=Moderate, Grade 3=Severe, Grade 4=Life-threatening, Grade 5=Death.
groups
  1. description
    Patients received oral American ginseng twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment.
    id
    OG000
    title
    Ginseng
  2. description
    Patients received oral placebo twice daily for 14 days. This treatment was repeated every two weeks for 4 courses, for a total of 8 weeks of treatment..
    id
    OG001
    title
    Placebo
param Type
NUMBER
population Description
Includes all participants that reported at least one value after baseline.
reporting Status
POSTED
time Frame
Week 1 to Week 8
title
Number of Treatment Related Grade 2 to 3 Adverse Events >=1% Incidence
type
SECONDARY
unit Of Measure
participants

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

Preserved source evidence · Not medical advice