NCT00370331 · OUTCOME

WHO Bleeding Scale

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, all nominal visits on-therapy defined as Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Week 10, Week 14, Week 18, Week 22, Week 26, and 1, 2 and 4 week follow-up visits

What was measured

Summary of World Health Organization (WHO) bleeding scores at each nominal visit. WHO Grades 1-4 = any bleeding; WHO Grades 2-4 = clinically significant bleeding

Analysis population: ITT Population

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

Group	Source count
Placebo	62
Eltrombopag 50 mg QD	135

Reported measurements

Baseline, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	77	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	73	Not reported	Not reported	Not reported	Not reported

Day 8, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	73	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	56	Not reported	Not reported	Not reported	Not reported

Day 15, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	68	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	39	Not reported	Not reported	Not reported	Not reported

Day 22, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	67	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	38	Not reported	Not reported	Not reported	Not reported

Day 29, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	56	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	37	Not reported	Not reported	Not reported	Not reported

Day 36, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	66	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	23	Not reported	Not reported	Not reported	Not reported

Day 43, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	59	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	23	Not reported	Not reported	Not reported	Not reported

Week 10, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	49	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	22	Not reported	Not reported	Not reported	Not reported

Week 14, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	57	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	23	Not reported	Not reported	Not reported	Not reported

Week 18, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	59	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	22	Not reported	Not reported	Not reported	Not reported

Week 22, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	46	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	18	Not reported	Not reported	Not reported	Not reported

Week 26, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	56	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	22	Not reported	Not reported	Not reported	Not reported

1 Week Follow-up, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	59	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	28	Not reported	Not reported	Not reported	Not reported

2 Week Follow-up, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	56	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	50	Not reported	Not reported	Not reported	Not reported

4 Week Follow-up, WHO Grades 1-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	59	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	46	Not reported	Not reported	Not reported	Not reported

Baseline, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	28	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	22	Not reported	Not reported	Not reported	Not reported

Day 8, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	20	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	16	Not reported	Not reported	Not reported	Not reported

Day 15, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	22	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	8	Not reported	Not reported	Not reported	Not reported

Day 22, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	21	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	11	Not reported	Not reported	Not reported	Not reported

Day 29, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	19	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	10	Not reported	Not reported	Not reported	Not reported

Day 36, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	19	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	7	Not reported	Not reported	Not reported	Not reported

Day 43, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	19	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	5	Not reported	Not reported	Not reported	Not reported

Week 10, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	13	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	9	Not reported	Not reported	Not reported	Not reported

Week 14, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	17	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	5	Not reported	Not reported	Not reported	Not reported

Week 18, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	18	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	2	Not reported	Not reported	Not reported	Not reported

Week 22, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	10	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	8	Not reported	Not reported	Not reported	Not reported

Week 26, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	15	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	7	Not reported	Not reported	Not reported	Not reported

1 Week Follow-up, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	20	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	11	Not reported	Not reported	Not reported	Not reported

2 Week Follow-up, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	18	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	16	Not reported	Not reported	Not reported	Not reported

4 Week Follow-up, WHO Grades 2-4

Values in Percentage of participants · Interval/dispersion: Not reported
Group	Value	Spread	Lower	Upper	Comment
Placebo	21	Not reported	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	13	Not reported	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
value
77
group Id
OG001
value
73
title
Baseline, WHO Grades 1-4
categories
measurements
group Id
OG000
value
73
group Id
OG001
value
56
title
Day 8, WHO Grades 1-4
categories
measurements
group Id
OG000
value
68
group Id
OG001
value
39
title
Day 15, WHO Grades 1-4
categories
measurements
group Id
OG000
value
67
group Id
OG001
value
38
title
Day 22, WHO Grades 1-4
categories
measurements
group Id
OG000
value
56
group Id
OG001
value
37
title
Day 29, WHO Grades 1-4
categories
measurements
group Id
OG000
value
66
group Id
OG001
value
23
title
Day 36, WHO Grades 1-4
categories
measurements
group Id
OG000
value
59
group Id
OG001
value
23
title
Day 43, WHO Grades 1-4
categories
measurements
group Id
OG000
value
49
group Id
OG001
value
22
title
Week 10, WHO Grades 1-4
categories
measurements
group Id
OG000
value
57
group Id
OG001
value
23
title
Week 14, WHO Grades 1-4
categories
measurements
group Id
OG000
value
59
group Id
OG001
value
22
title
Week 18, WHO Grades 1-4
categories
measurements
group Id
OG000
value
46
group Id
OG001
value
18
title
Week 22, WHO Grades 1-4
categories
measurements
group Id
OG000
value
56
group Id
OG001
value
22
title
Week 26, WHO Grades 1-4

denoms

counts
group Id
OG000
value
62
group Id
OG001
value
135
units
Participants

description

Summary of World Health Organization (WHO) bleeding scores at each nominal visit. WHO Grades 1-4 = any bleeding; WHO Grades 2-4 = clinically significant bleeding

groups

description
Matching placebo tablets taken once a day
id
OG000
title
Placebo
description
Eltrombopag 50 mg oral tablets taken once a day (QD)
id
OG001
title
Eltrombopag 50 mg QD

param Type

NUMBER

population Description

ITT Population

reporting Status

POSTED

time Frame

Baseline, all nominal visits on-therapy defined as Day 8, Day 15, Day 22, Day 29, Day 36, Day 43, Week 10, Week 14, Week 18, Week 22, Week 26, and 1, 2 and 4 week follow-up visits

title

WHO Bleeding Scale

type

SECONDARY

unit Of Measure

Percentage of participants

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Preserved source evidence · Not medical advice