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NCT00370331 · OUTCOME

Percentage of Responders

RAISE: Randomized Placebo-Controlled Idiopathic Thrombocytopenic Purpura (ITP) Study With Eltrombopag · Source last updated 2017-04-18

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
NUMBER
Unit
Percentage of participants
Interval / dispersion
Not reported
Time frame
Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment

What was measured

The percentage of evaluable participants who achieved a platelet response (defined as a platelet count between 50,000 and 400,000 microliter) at each nominal on-therapy day and 4 weeks post-treatment

Analysis population: Intent-to-Treat (ITT) Population: all randomized participants

Groups in this outcome

Placebo

Matching placebo tablets taken once a day

Eltrombopag 50 mg QD

Eltrombopag 50 mg oral tablets taken once a day (QD)

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

Analysis denominator · Participants

GroupSource count
Placebo62
Eltrombopag 50 mg QD135

Reported measurements

Baseline
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo2Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD1Not reportedNot reportedNot reportedNot reported
Day 8
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo7Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD37Not reportedNot reportedNot reportedNot reported
Day 15
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo8Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD46Not reportedNot reportedNot reportedNot reported
Day 22
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo8Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD51Not reportedNot reportedNot reportedNot reported
Day 29
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo10Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD49Not reportedNot reportedNot reportedNot reported
Day 36
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo8Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD56Not reportedNot reportedNot reportedNot reported
Day 43
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo14Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD54Not reportedNot reportedNot reportedNot reported
Week 10
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo17Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD52Not reportedNot reportedNot reportedNot reported
Week 14
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo18Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD46Not reportedNot reportedNot reportedNot reported
Week 18
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo17Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD46Not reportedNot reportedNot reportedNot reported
Week 22
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo19Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD49Not reportedNot reportedNot reportedNot reported
Week 26
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo17Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD52Not reportedNot reportedNot reportedNot reported
1 Week Follow-up
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo15Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD42Not reportedNot reportedNot reportedNot reported
2 Week Follow-up
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo18Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD22Not reportedNot reportedNot reportedNot reported
4 Week Follow-up
Values in Percentage of participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Placebo14Not reportedNot reportedNot reportedNot reported
Eltrombopag 50 mg QD20Not reportedNot reportedNot reportedNot reported

Source statistical analyses

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

  1. ci Lower Limit
    3.59
    ci Pct Value
    99
    ci Upper Limit
    18.73
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    8.2
    statistical Comment
    Repeated measures model for binary data using Generalized Estimating Equations (GEE)
    statistical Method
    Repeated measures model for binary data
Complete source fields
analyses
  1. ci Lower Limit
    3.59
    ci Pct Value
    99
    ci Upper Limit
    18.73
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    SUPERIORITY_OR_OTHER
    p Value
    <0.001
    param Type
    Odds Ratio (OR)
    param Value
    8.2
    statistical Comment
    Repeated measures model for binary data using Generalized Estimating Equations (GEE)
    statistical Method
    Repeated measures model for binary data
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        1
    title
    Baseline
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        7
      2. group Id
        OG001
        value
        37
    title
    Day 8
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        46
    title
    Day 15
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        51
    title
    Day 22
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        10
      2. group Id
        OG001
        value
        49
    title
    Day 29
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        8
      2. group Id
        OG001
        value
        56
    title
    Day 36
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        14
      2. group Id
        OG001
        value
        54
    title
    Day 43
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        52
    title
    Week 10
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        18
      2. group Id
        OG001
        value
        46
    title
    Week 14
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        46
    title
    Week 18
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        19
      2. group Id
        OG001
        value
        49
    title
    Week 22
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        17
      2. group Id
        OG001
        value
        52
    title
    Week 26
denoms
  1. counts
    1. group Id
      OG000
      value
      62
    2. group Id
      OG001
      value
      135
    units
    Participants
description
The percentage of evaluable participants who achieved a platelet response (defined as a platelet count between 50,000 and 400,000 microliter) at each nominal on-therapy day and 4 weeks post-treatment
groups
  1. description
    Matching placebo tablets taken once a day
    id
    OG000
    title
    Placebo
  2. description
    Eltrombopag 50 mg oral tablets taken once a day (QD)
    id
    OG001
    title
    Eltrombopag 50 mg QD
param Type
NUMBER
population Description
Intent-to-Treat (ITT) Population: all randomized participants
reporting Status
POSTED
time Frame
Baseline; each on-therapy treatment day; Weeks 10, 14, 18, 22, and 26; and Weeks 1, 2, and 4 post-treatment
title
Percentage of Responders
type
PRIMARY
unit Of Measure
Percentage of participants

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice