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 2/3
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 of Part 2/3 through Follow-up
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/ 3 (Eltrombopag Period) Cohort 1
All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2/3 (Eltrombopag Period) Cohort 2
All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of \<=27 kg received 25 mg QD and participants with a body weight of \>=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2/3 (Eltrombopag Period) Cohort 3
All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the studyat 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 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/ 3 (Eltrombopag Period) Cohort 1
24
Part 2/3 (Eltrombopag Period) Cohort 2
28
Part 2/3 (Eltrombopag Period) Cohort 3
15
Reported measurements
Baseline, Grades 1-4, n=24, 28, 15
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
23
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
18
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
12
Not reported
Not reported
Not reported
Not reported
Baseline, Grades 0-1, n=24, 28, 15
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
17
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
25
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
9
Not reported
Not reported
Not reported
Not reported
Baseline, Grades 2-4, n=24, 28, 15
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
7
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
6
Not reported
Not reported
Not reported
Not reported
Week 1, Grades 1-4, n=24, 26, 15
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
14
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
13
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
9
Not reported
Not reported
Not reported
Not reported
Week 1, Grades 0-1, n=24, 26, 15
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
20
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
24
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
9
Not reported
Not reported
Not reported
Not reported
Week 1, Grades 2-4, n=24, 26, 15
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
4
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
6
Not reported
Not reported
Not reported
Not reported
Week 2, Grades 1-4, n=24, 26, 14
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
15
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
12
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
8
Not reported
Not reported
Not reported
Not reported
Week 2, Grades 0-1, n=24, 26, 14
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
21
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
23
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
10
Not reported
Not reported
Not reported
Not reported
Week 2, Grades 2-4, n=24, 26, 14
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
4
Not reported
Not reported
Not reported
Not reported
Week 3, Grades 1-4, n=24, 25, 14
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
13
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
9
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
6
Not reported
Not reported
Not reported
Not reported
Week 3, Grades 0-1, n=24, 25, 14
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
21
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
23
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
12
Not reported
Not reported
Not reported
Not reported
Week 3, Grades 2-4, n=24, 25, 14
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Week 4, Grades 1-4, n=24, 26, 13
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
10
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
11
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
8
Not reported
Not reported
Not reported
Not reported
Week 4, Grades 0-1, n=24, 26, 13
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
24
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
26
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
10
Not reported
Not reported
Not reported
Not reported
Week 4, Grades 2-4, n=24, 26, 13
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
3
Not reported
Not reported
Not reported
Not reported
Week 5, Grades 1-4, n=24, 24, 13
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
11
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
4
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
9
Not reported
Not reported
Not reported
Not reported
Week 5, Grades 0-1, n=24, 24, 13
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
21
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
24
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
12
Not reported
Not reported
Not reported
Not reported
Week 5, Grades 2-4, n=24, 24, 13
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Week 6, Grades 1-4, n=23, 24, 12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
6
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
6
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
4
Not reported
Not reported
Not reported
Not reported
Week 6, Grades 0-1, n=23, 24, 12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
23
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
22
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
12
Not reported
Not reported
Not reported
Not reported
Week 6, Grades 2-4, n=23, 24, 12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Week 7, Grades 1-4, n=22, 25, 14
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
8
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
7
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
4
Not reported
Not reported
Not reported
Not reported
Week 7, Grades 0-1, n=22, 25, 14
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
20
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
24
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
12
Not reported
Not reported
Not reported
Not reported
Week 7, Grades 2-4, n=22, 25, 14
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Week 8, Grades 1-4, n=19, 21, 11
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
10
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
6
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
5
Not reported
Not reported
Not reported
Not reported
Week 8, Grades 0-1, n=19, 21, 11
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
19
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
19
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
9
Not reported
Not reported
Not reported
Not reported
Week 8, Grades 2-4, n=19, 21, 11
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Week 9, Grades 1-4, n=17, 16, 12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
8
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
5
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
6
Not reported
Not reported
Not reported
Not reported
Week 9, Grades 0-1, n=17, 16, 12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
13
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
16
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
10
Not reported
Not reported
Not reported
Not reported
Week 9, Grades 2-4, n=17, 16, 12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
4
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Week 10, Grades 1-4, n=16, 14, 11
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
5
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
5
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
7
Not reported
Not reported
Not reported
Not reported
Week 10, Grades 0-1, n=16, 14, 11
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
16
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
12
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
11
Not reported
Not reported
Not reported
Not reported
Week 10, Grades 2-4, n=16, 14, 11
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Week 11, Grades 1-4, n=16, 15, 12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
15
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
5
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
7
Not reported
Not reported
Not reported
Not reported
Week 11, Grades 0-1, n=16, 15, 12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
16
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
13
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
10
Not reported
Not reported
Not reported
Not reported
Week 11, Grades 2-4, n=16, 15, 12
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Week 12, Grades 1-4, n=19, 16, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
6
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
7
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
4
Not reported
Not reported
Not reported
Not reported
Week 12, Grades 0-1, n=19, 16, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
18
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
14
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
7
Not reported
Not reported
Not reported
Not reported
Week 12, Grades 2-4, n=19, 16, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Week 13, Grades 1-4, n=12, 14, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
6
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
5
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
6
Not reported
Not reported
Not reported
Not reported
Week 13, Grades 0-1, n=12, 14, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
12
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
13
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
10
Not reported
Not reported
Not reported
Not reported
Week 13, Grades 2-4, n=12, 14, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Week 14, Grades 1-4, n=15, 11, 17
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
3
Not reported
Not reported
Not reported
Not reported
Week 14, Grades 0-1, n=15, 11, 17
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
15
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
11
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
5
Not reported
Not reported
Not reported
Not reported
Week 14, Grades 2-4, n=15, 11, 17
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Week 15, Grades 1-4, n=12, 14, 6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
6
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
3
Not reported
Not reported
Not reported
Not reported
Week 15, Grades 0-1, n=12, 14, 6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
10
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
14
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
5
Not reported
Not reported
Not reported
Not reported
Week 15, Grades 2-4, n=12, 14, 6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Week 16, Grades 1-4, n=17, 15, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
7
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
8
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
4
Not reported
Not reported
Not reported
Not reported
Week 16, Grades 0-1, n=17, 15, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
17
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
14
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
9
Not reported
Not reported
Not reported
Not reported
Week 16, Grades 2-4, n=17, 15, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Week 17, Grades 1-4, n=13, 11, 5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
5
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
4
Not reported
Not reported
Not reported
Not reported
Week 17, Grades 0-1, n=13, 11, 5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
13
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
11
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
5
Not reported
Not reported
Not reported
Not reported
Week 17, Grades 2-4, n=13, 11, 5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Week 18, Grades 1-4, n=16, 12 ,4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
3
Not reported
Not reported
Not reported
Not reported
Week 18, Grades 0-1, n=16, 12 ,4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
16
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
11
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
4
Not reported
Not reported
Not reported
Not reported
Week 18, Grades 2-4, n=16, 12 ,4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Week 19, Grades 1-4, n=14, 15, 7
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
4
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Week 19, Grades 0-1, n=14, 15, 7
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
14
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
14
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
7
Not reported
Not reported
Not reported
Not reported
Week 19, Grades 2-4, n=14, 15, 7
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Week 20, Grades 1-4, n=13, 13, 8
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Week 20, Grades 0-1, n=13, 13, 8
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
13
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
13
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
6
Not reported
Not reported
Not reported
Not reported
Week 20, Grades 2-4, n=13, 13, 8
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Week 21, Grades 1-4, n=4, 10, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Week 21, Grades 0-1, n=4, 10, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
4
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
10
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
3
Not reported
Not reported
Not reported
Not reported
Week 21, Grades 2-4, n=4, 10, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Week 22, Grades 1-4, n=12,7, 5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Week 22 Grades 0-1, n=12,7, 5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
12
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
6
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
5
Not reported
Not reported
Not reported
Not reported
Week 22 Grades 2-4, n=12,7, 5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Week 23, Grades 1-4, n=8, 7,6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Week 23, Grades 0-1, n=8, 7,6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
8
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
7
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
6
Not reported
Not reported
Not reported
Not reported
Week 23, Grades 2-4, n=8, 7,6
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
0
Not reported
Not reported
Not reported
Not reported
Week 24, Grades 1-4, n=23, 24, 13
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
5
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
5
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
4
Not reported
Not reported
Not reported
Not reported
Week 24, Grades 0-1, n=23, 14, 13
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
21
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
24
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
12
Not reported
Not reported
Not reported
Not reported
Week 24, Grades 2-4, n=23, 14, 13
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Follow Up Week 1, Grades 1-4, n=8, 5, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
5
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
3
Not reported
Not reported
Not reported
Not reported
Follow Up Week 1, Grades 0-1, n=8, 5, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
8
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
4
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Follow Up Week 1, Grades 2-4, n=8, 5, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Follow Up Week 2, Grades 1-4, n=7, 7, 7
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
6
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
2
Not reported
Not reported
Not reported
Not reported
Follow Up Week 2, Grades 0-1, n=7, 7, 7
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
7
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
6
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
6
Not reported
Not reported
Not reported
Not reported
Follow Up Week 2, Grades 2-4, n=7, 7, 7
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Follow Up Week 3, Grades 1-4, n=5, 5, 5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
4
Not reported
Not reported
Not reported
Not reported
Follow Up Week 3, Grades 0-1, n=5, 5, 5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
5
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
5
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
4
Not reported
Not reported
Not reported
Not reported
Follow Up Week 3, Grades 2-4, n=5, 5, 5
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Follow Up Week 4, Grades 1-4, n=9, 14, 8
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
5
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
4
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
3
Not reported
Not reported
Not reported
Not reported
Follow Up Week 4, Grades 0-1, n=9, 14, 8
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
8
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
13
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
7
Not reported
Not reported
Not reported
Not reported
Follow Up Week 4, Grades 2-4, n=9, 14, 8
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
1
Not reported
Not reported
Not reported
Not reported
Any Follow Up Visit, Grades 1, n=15, 18, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
7
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
10
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
5
Not reported
Not reported
Not reported
Not reported
Any Follow Up Visit, Grades 0-1, n=15, 18, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
15
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
18
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
9
Not reported
Not reported
Not reported
Not reported
Any Follow Up Visit, Grades 2-4, n=15, 18, 10
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2/ 3 (Eltrombopag Period) Cohort 1
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
3
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
23
group Id
OG001
value
18
group Id
OG002
value
12
title
Baseline, Grades 1-4, n=24, 28, 15
categories
measurements
group Id
OG000
value
17
group Id
OG001
value
25
group Id
OG002
value
9
title
Baseline, Grades 0-1, n=24, 28, 15
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
3
group Id
OG002
value
6
title
Baseline, Grades 2-4, n=24, 28, 15
categories
measurements
group Id
OG000
value
14
group Id
OG001
value
13
group Id
OG002
value
9
title
Week 1, Grades 1-4, n=24, 26, 15
categories
measurements
group Id
OG000
value
20
group Id
OG001
value
24
group Id
OG002
value
9
title
Week 1, Grades 0-1, n=24, 26, 15
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
2
group Id
OG002
value
6
title
Week 1, Grades 2-4, n=24, 26, 15
categories
measurements
group Id
OG000
value
15
group Id
OG001
value
12
group Id
OG002
value
8
title
Week 2, Grades 1-4, n=24, 26, 14
categories
measurements
group Id
OG000
value
21
group Id
OG001
value
23
group Id
OG002
value
10
title
Week 2, Grades 0-1, n=24, 26, 14
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
4
title
Week 2, Grades 2-4, n=24, 26, 14
categories
measurements
group Id
OG000
value
13
group Id
OG001
value
9
group Id
OG002
value
6
title
Week 3, Grades 1-4, n=24, 25, 14
categories
measurements
group Id
OG000
value
21
group Id
OG001
value
23
group Id
OG002
value
12
title
Week 3, Grades 0-1, n=24, 25, 14
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
2
title
Week 3, Grades 2-4, n=24, 25, 14
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
28
group Id
OG002
value
15
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
All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
id
OG000
title
Part 2/ 3 (Eltrombopag Period) Cohort 1
description
All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of \<=27 kg received 25 mg QD and participants with a body weight of \>=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. 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 2/3 (Eltrombopag Period) Cohort 2
description
All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Particpiants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the studyat 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
id
OG002
title
Part 2/3 (Eltrombopag Period) Cohort 3
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 of Part 2/3 through Follow-up
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 2/3
Triangle