Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP) · Source last updated 2018-10-12
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
From Baseline through Week 7 of Part 2
What was measured
The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2.
Analysis population: ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
Groups in this outcome
Part 2 (Randomized Period) Cohort 1-Placebo
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
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
Part 2 (Randomized Period) Cohort 1-Placebo
8
Part 2 (Randomized Period) Cohort 1- Eltrombopag
16
Part 2 (Randomized Period) Cohort 2-Placebo
9
Part 2 (Randomized Period) Cohort 2-Eltrombopag
19
Part 2 (Randomized Period) Cohort 3-Placebo
5
Part 2 (Randomized Period) Cohort 3- Eltrombopag
10
Reported measurements
Baseline, Grades 1-4, n=8, 16, 9, 19, 5, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
16
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
11
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
5
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
Baseline, Grades 0-1, n=8, 16, 9, 19, 5, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
13
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
17
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
Baseline, Grades 2-4, n=8, 16, 9, 19, 5, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Week 1, Grades 1-4, n=8, 16, 9, 17, 5, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
9
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
Week 1, Grades 0-1, n=8, 16, 9, 17, 5, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
14
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
17
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
5
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
Week 1, Grades 2-4, n=8, 16, 9, 17, 5, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
5
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
Week 2, Grades 1-4, n=8, 16, 9, 17, 5, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
11
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
Week 2, Grades 0-1, n=8, 16, 9, 17, 5, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
5
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
13
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
16
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
Week 2, Grades 2-4, n=8, 16, 9, 17, 5, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Week 3, Grades 1-4, n=8, 16, 9, 16, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
10
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
Week 3, Grades 0-1, n=8, 16, 9, 16, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
5
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
14
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
14
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
Week 3, Grades 2-4, n=8, 16, 9, 16, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Week 4, Grades 1-4, n=8, 16, 9, 17, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
Week 4, Grades 0-1, n=8, 16, 9, 17, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
16
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
8
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
17
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
Week 4, Grades 2-4, n=8, 16, 9, 17, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Week 5, Grades 1-4, n=8, 16, 9, 16, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
Week 5, Grades 0-1, n=8, 16, 9, 16, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
14
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
8
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
16
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
Week 5, Grades 2-4, n=8, 16, 9, 16, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Week 6, Grades 1-4, n=8, 16, 9, 17, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
5
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Week 6, Grades 0-1, n=8, 16, 9, 17, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
16
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
16
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
9
Not reported
Not reported
Not reported
Not reported
Week 6, Grades 2-4, n=8, 16, 9, 17, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Week 7, Grades 1-4, n=8, 16, 9, 17, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Week 7, Grades 0-1, n=8, 16, 9, 17, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
15
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
8
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
16
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
Week 7, Grades 2-4, n=8, 16, 9, 17, 5, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Randomized Period) Cohort 1-Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 1- Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 2-Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3-Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) Cohort 3- Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
16
group Id
OG002
value
7
group Id
OG003
value
11
group Id
OG004
value
5
group Id
OG005
value
8
title
Baseline, Grades 1-4, n=8, 16, 9, 19, 5, 10
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
13
group Id
OG002
value
6
group Id
OG003
value
17
group Id
OG004
value
4
group Id
OG005
value
6
title
Baseline, Grades 0-1, n=8, 16, 9, 19, 5, 10
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
2
group Id
OG004
value
1
group Id
OG005
value
4
title
Baseline, Grades 2-4, n=8, 16, 9, 19, 5, 10
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
9
group Id
OG002
value
6
group Id
OG003
value
7
group Id
OG004
value
3
group Id
OG005
value
7
title
Week 1, Grades 1-4, n=8, 16, 9, 17, 5, 10
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
14
group Id
OG002
value
6
group Id
OG003
value
17
group Id
OG004
value
5
group Id
OG005
value
5
title
Week 1, Grades 0-1, n=8, 16, 9, 17, 5, 10
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
2
group Id
OG002
value
3
group Id
OG003
value
0
group Id
OG004
value
0
group Id
OG005
value
5
title
Week 1, Grades 2-4, n=8, 16, 9, 17, 5, 10
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
11
group Id
OG002
value
6
group Id
OG003
value
6
group Id
OG004
value
2
group Id
OG005
value
5
title
Week 2, Grades 1-4, n=8, 16, 9, 17, 5, 10
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
13
group Id
OG002
value
7
group Id
OG003
value
16
group Id
OG004
value
3
group Id
OG005
value
7
title
Week 2, Grades 0-1, n=8, 16, 9, 17, 5, 10
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
1
group Id
OG004
value
2
group Id
OG005
value
3
title
Week 2, Grades 2-4, n=8, 16, 9, 17, 5, 10
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
10
group Id
OG002
value
7
group Id
OG003
value
6
group Id
OG004
value
2
group Id
OG005
value
5
title
Week 3, Grades 1-4, n=8, 16, 9, 16, 5, 9
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
14
group Id
OG002
value
7
group Id
OG003
value
14
group Id
OG004
value
3
group Id
OG005
value
7
title
Week 3, Grades 0-1, n=8, 16, 9, 16, 5, 9
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
2
group Id
OG004
value
2
group Id
OG005
value
2
title
Week 3, Grades 2-4, n=8, 16, 9, 16, 5, 9
denoms
counts
group Id
OG000
value
8
group Id
OG001
value
16
group Id
OG002
value
9
group Id
OG003
value
19
group Id
OG004
value
5
group Id
OG005
value
10
units
Participants
description
The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2.
groups
description
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
id
OG000
title
Part 2 (Randomized Period) Cohort 1-Placebo
description
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
id
OG001
title
Part 2 (Randomized Period) Cohort 1- Eltrombopag
description
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
id
OG002
title
Part 2 (Randomized Period) Cohort 2-Placebo
description
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
id
OG003
title
Part 2 (Randomized Period) Cohort 2-Eltrombopag
description
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
id
OG004
title
Part 2 (Randomized Period) Cohort 3-Placebo
description
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
id
OG005
title
Part 2 (Randomized Period) Cohort 3- Eltrombopag
param Type
NUMBER
population Description
ITT Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,X in the category titles). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT Population.
reporting Status
POSTED
time Frame
From Baseline through Week 7 of Part 2
title
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Triangle