NCT00370331 · OUTCOME

HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment

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: MEAN
Unit: Points on a scale (0-100)
Interval / dispersion: Standard Deviation
Time frame: Baseline, Week 6, Week 14, and Week 26/Early Withdrawal

What was measured

Health-related quality of life (HR-QoL) patient reported outcomes from the short form-36v2 (SF-36v2) questionnaire. Scores could range from 0 (worst possible) to 100 (best possible).

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

SF-36v2 physical function, Baseline

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	75.0	21.7	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	73.1	26.8	Not reported	Not reported	Not reported

SF-36v2 physical function, Week 6

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	76.5	20.8	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	78.0	24.4	Not reported	Not reported	Not reported

SF-36v2 physical function, Week 14

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	77.6	20.0	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	78.9	22.5	Not reported	Not reported	Not reported

SF-36v2 physical funct., Week 26/Early Withdrawal

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	75.8	22.6	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	80.6	21.7	Not reported	Not reported	Not reported

SF-36v2 physical role, Baseline

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	64.5	26.7	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	64.5	30.5	Not reported	Not reported	Not reported

SF-36v2 physical role, Week 6

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	66.9	25.4	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	73.7	27.4	Not reported	Not reported	Not reported

SF-36v2 physical role, Week 14

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	67.2	25.8	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	72.9	24.9	Not reported	Not reported	Not reported

SF-36v2 physical role, Week 26/Early Withdrawal

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	67.5	27.1	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	73.7	25.4	Not reported	Not reported	Not reported

SF-36v2 bodily pain, Baseline

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	70.0	23.2	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	75.2	27.8	Not reported	Not reported	Not reported

SF-36v2 bodily pain, Week 6

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	69.9	25.9	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	78.5	25.4	Not reported	Not reported	Not reported

SF-36v2 bodily pain, Week 14

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	68.3	24.8	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	77.6	25.8	Not reported	Not reported	Not reported

SF-36v2 bodily pain, Week 26/Early Withdrawal

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	68.5	25.0	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	75.7	26.6	Not reported	Not reported	Not reported

SF-36v2 general health, Baseline

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	53.7	21.8	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	56.0	21.3	Not reported	Not reported	Not reported

SF-36v2 general health, Week 6

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	55.9	21.4	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	59.7	21.5	Not reported	Not reported	Not reported

SF-36v2 general health, Week 14

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	52.8	23.2	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	59.3	20.7	Not reported	Not reported	Not reported

SF-36v2 general health, Week 26/Early Withdrawal

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	53.3	24.9	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	57.3	23.1	Not reported	Not reported	Not reported

SF-36v2 vitality, Baseline

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	56.7	20.2	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	55.1	26.3	Not reported	Not reported	Not reported

SF-36v2 vitality, Week 6

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	59.0	20.0	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	62.1	22.7	Not reported	Not reported	Not reported

SF-36v2 vitality, Week 14

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	56.8	22.3	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	61.0	22.4	Not reported	Not reported	Not reported

SF-36v2 vitality, Week 26/Early Withdrawal

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	57.5	22.4	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	60.0	23.3	Not reported	Not reported	Not reported

SF-36v2 social function, Baseline

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	76.1	21.7	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	72.7	28.3	Not reported	Not reported	Not reported

SF-36v2 social function, Week 6

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	78.0	21.4	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	77.6	26.2	Not reported	Not reported	Not reported

SF-36v2 social function, Week 14

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	73.4	25.8	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	78.4	22.6	Not reported	Not reported	Not reported

SF-36v2 social function, Week 26/Early Withdrawal

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	75.0	25.8	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	79.0	24.2	Not reported	Not reported	Not reported

SF-36v2 emotional role, Baseline

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	73.4	25.4	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	69.1	30.9	Not reported	Not reported	Not reported

SF-36v2 emotional role, Week 6

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	73.1	24.6	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	77.5	25.9	Not reported	Not reported	Not reported

SF-36v2 emotional role, Week 14

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	73.3	22.9	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	74.1	25.2	Not reported	Not reported	Not reported

SF-36v2 emotional role, Week 26/Early Withdrawal

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	71.5	26.5	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	76.9	25.4	Not reported	Not reported	Not reported

SF-36v2 mental health, Baseline

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	70.3	18.7	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	68.0	21.0	Not reported	Not reported	Not reported

SF-36v2 mental health, Week 6

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	71.7	18.3	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	71.8	19.0	Not reported	Not reported	Not reported

SF-36v2 mental health, Week 14

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	68.6	20.4	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	70.6	19.3	Not reported	Not reported	Not reported

SF-36v2 mental health, Week 26/Early Withdrawal

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	68.6	22.8	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	70.2	21.6	Not reported	Not reported	Not reported

SF-36v physical component summary, Baseline

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	45.6	8.3	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	46.9	9.7	Not reported	Not reported	Not reported

SF-36v physical component summary, Week 6

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	46.2	8.3	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	48.7	9.0	Not reported	Not reported	Not reported

SF-36v physical component summary, Week 14

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	46.3	8.3	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	49.0	8.1	Not reported	Not reported	Not reported

SF-36v physical component summary, Week 26/EW

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	46.2	8.1	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	48.7	8.6	Not reported	Not reported	Not reported

SF-36v2 mental component summary, Baseline

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	46.4	10.1	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	44.3	12.6	Not reported	Not reported	Not reported

SF-36v2 mental component summary, Week 6

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	46.8	10.0	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	47.2	11.1	Not reported	Not reported	Not reported

SF-36v2 mental component summary, Week 14

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	45.3	11.1	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	46.2	11.3	Not reported	Not reported	Not reported

SF-36v2 mental component summary, Week 26/EW

Values in Points on a scale (0-100) · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo	45.2	12.3	Not reported	Not reported	Not reported
Eltrombopag 50 mg QD	46.5	12.4	Not reported	Not reported	Not reported

Complete source fields

classes

categories
measurements
group Id
OG000
spread
21.7
value
75.0
group Id
OG001
spread
26.8
value
73.1
title
SF-36v2 physical function, Baseline
categories
measurements
group Id
OG000
spread
20.8
value
76.5
group Id
OG001
spread
24.4
value
78.0
title
SF-36v2 physical function, Week 6
categories
measurements
group Id
OG000
spread
20.0
value
77.6
group Id
OG001
spread
22.5
value
78.9
title
SF-36v2 physical function, Week 14
categories
measurements
group Id
OG000
spread
22.6
value
75.8
group Id
OG001
spread
21.7
value
80.6
title
SF-36v2 physical funct., Week 26/Early Withdrawal
categories
measurements
group Id
OG000
spread
26.7
value
64.5
group Id
OG001
spread
30.5
value
64.5
title
SF-36v2 physical role, Baseline
categories
measurements
group Id
OG000
spread
25.4
value
66.9
group Id
OG001
spread
27.4
value
73.7
title
SF-36v2 physical role, Week 6
categories
measurements
group Id
OG000
spread
25.8
value
67.2
group Id
OG001
spread
24.9
value
72.9
title
SF-36v2 physical role, Week 14
categories
measurements
group Id
OG000
spread
27.1
value
67.5
group Id
OG001
spread
25.4
value
73.7
title
SF-36v2 physical role, Week 26/Early Withdrawal
categories
measurements
group Id
OG000
spread
23.2
value
70.0
group Id
OG001
spread
27.8
value
75.2
title
SF-36v2 bodily pain, Baseline
categories
measurements
group Id
OG000
spread
25.9
value
69.9
group Id
OG001
spread
25.4
value
78.5
title
SF-36v2 bodily pain, Week 6
categories
measurements
group Id
OG000
spread
24.8
value
68.3
group Id
OG001
spread
25.8
value
77.6
title
SF-36v2 bodily pain, Week 14
categories
measurements
group Id
OG000
spread
25.0
value
68.5
group Id
OG001
spread
26.6
value
75.7
title
SF-36v2 bodily pain, Week 26/Early Withdrawal

denoms

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

description

Health-related quality of life (HR-QoL) patient reported outcomes from the short form-36v2 (SF-36v2) questionnaire. Scores could range from 0 (worst possible) to 100 (best possible).

dispersion Type

Standard Deviation

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

MEAN

population Description

ITT Population

reporting Status

POSTED

time Frame

Baseline, Week 6, Week 14, and Week 26/Early Withdrawal

title

HR-QoL Instrument and Domain Scores From the SF-36v2 Questionnaire at Baseline, Week 6, Week 14, and Week 26 or Early Discontinuation From Study Treatment

type

SECONDARY

unit Of Measure

Points on a scale (0-100)

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

Preserved source evidence · Not medical advice