Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and 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 through Study Week 35
What was measured
Vital sign assessments included systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements that were measured before any blood draw at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, at each Follow-up week (Week 1-4) and the maximum post- Baseline (BL) visit. BL is defined as the value obtained on Day 1of treatment. The maximum post-BL visit (MPB) included any scheduled and unscheduled post-BL assessment. Reference ranges (RR) for SBP (mmHg) (Lower limit of normal, normal, Upper limit of normal) for Cohort 1: \<85, 85-115, \>115; for Cohort 2: \<85, 85-120,\>120; and Cohort 3: \<95, 95-135, \>135. RR for DBP (mmHg) for Cohort 1: \<45, 45-70,\>70; for Cohort 2: \<50, 50-75, \>75; and Cohort 3: \<55, 55-85, \>85.
Analysis population: Safety 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 Safety Population.
Groups in this outcome
Part 1 Eltrombopag Dose-Finding Period
Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a bodyweight of \<27 kg received 12.5 mg QD, par with a body weight of \>=27 kg received 25 mg QD; par of east Asian ancestry with a body weight \<27 kg received 12.5 mg QD, and with a body weight of \>=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
Part 2 Randomized Period - Placebo
Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
Part 2 Randomized Period - Eltrombopag
Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of \<27 kg received 25 mg QD, and par with a body weight of \>=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD, and with a body weight of \>=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
Part 2/ 3 (Eltrombopag Open-Label Period)
Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
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 1 Eltrombopag Dose-Finding Period
15
Part 2 Randomized Period - Placebo
21
Part 2 Randomized Period - Eltrombopag
44
Part 2/ 3 (Eltrombopag Open-Label Period)
65
Reported measurements
Screening, DBP, high, n=15 ,20 ,41 ,40
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Screening, DBP, low, n=15, 20, 41, 40
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
5
Not reported
Not reported
Not reported
Not reported
Day 1, DBP, high, n=14, 18, 38, 59
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
7
Not reported
Not reported
Not reported
Not reported
Day 1, DBP, low, n=14, 18, 38, 59
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
4
Not reported
Not reported
Not reported
Not reported
Week 1, DBP, high, n=14, 19, 42, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
5
Not reported
Not reported
Not reported
Not reported
Week 1, DBP, low, n=14, 19, 42, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
5
Not reported
Not reported
Not reported
Not reported
Week 2, DBP, high, n=15, 20, 42, 61
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 2, DBP, low, n=15, 20, 42, 61
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
5
Not reported
Not reported
Not reported
Not reported
Week 3, DBP, high,n=15, 21, 41, 60
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
6
Not reported
Not reported
Not reported
Not reported
Week 3, DBP, low,n=15, 21, 41, 60
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
5
Not reported
Not reported
Not reported
Not reported
Week 4, DBP,high, n=15, 21, 42, 62
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
6
Not reported
Not reported
Not reported
Not reported
Week 4, DBP,low, n=15, 21, 42, 62
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
5
Not reported
Not reported
Not reported
Not reported
Week 5, DBP, high, n=15, 19, 40, 59
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
8
Not reported
Not reported
Not reported
Not reported
Week 5, DBP, low, n=15, 19, 40, 59
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
5
Not reported
Not reported
Not reported
Not reported
Week 6, DBP, high, n=14, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
5
Not reported
Not reported
Not reported
Not reported
Week 6, DBP, low, n=14, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
4
Not reported
Not reported
Not reported
Not reported
Week 7, DBP, high, n=15, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
7
Not reported
Not reported
Not reported
Not reported
Week 7, DBP, low, n=15, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
4
Not reported
Not reported
Not reported
Not reported
Week 8, DBP,high,n=15, 0, 0, 49
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
4
Not reported
Not reported
Not reported
Not reported
Week 8, DBP,low,n=15, 0, 0, 49
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
6
Not reported
Not reported
Not reported
Not reported
Week 9, DBP, high, n=15, 0, 0, 45
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
4
Not reported
Not reported
Not reported
Not reported
Week 9, DBP, low, n=15, 0, 0, 45
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
6
Not reported
Not reported
Not reported
Not reported
Week 10, DBP, high, n=15, 0, 0, 40
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
6
Not reported
Not reported
Not reported
Not reported
Week 10, DBP, low, n=15, 0, 0, 40
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 11, DBP, high, n=13, 0, 0, 41
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
4
Not reported
Not reported
Not reported
Not reported
Week 11, DBP, low, n=13, 0, 0, 41
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 12, DBP, high, n=13, 0, 0, 42
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
5
Not reported
Not reported
Not reported
Not reported
Week 12, DBP, low, n=13, 0, 0, 42
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 13, DBP, high, n=12, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
0
Not reported
Not reported
Not reported
Not reported
Week 13, DBP, low, n=12, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
5
Not reported
Not reported
Not reported
Not reported
Week 14, DBP, high, n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 14, DBP, low, n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 15, DBP, high, n=11, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 15, DBP, low, n=11, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
0
Not reported
Not reported
Not reported
Not reported
Week 16, DBP,high,n=12, 0, 0, 39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
2
Not reported
Not reported
Not reported
Not reported
Week 16, DBP,low,n=12, 0, 0, 39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 17, DBP,high,n=5, 0, 0, 29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
2
Not reported
Not reported
Not reported
Not reported
Week 17, DBP,low,n=5, 0, 0, 29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
Week 18, DBP,high,n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 18, DBP,low,n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
Week 19, DBP,high,n=5, 0, 0, 34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
Week 19, DBP,low,n=5, 0, 0, 34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
2
Not reported
Not reported
Not reported
Not reported
Week 20, DBP,high,n=13, 0, 0, 33
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
0
Not reported
Not reported
Not reported
Not reported
Week 20, DBP,low,n=13, 0, 0, 33
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
Week 21, DBP,high,n=10, 0, 0, 17
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
Week 21, DBP,low,n=10, 0, 0, 17
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
Week 22, DBP,high,n=11, 0, 0, 23
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
Week 22, DBP,low,n=11, 0, 0, 23
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
0
Not reported
Not reported
Not reported
Not reported
Week 23, DBP,high,n=11, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
Week 23, DBP,low,n=11, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
2
Not reported
Not reported
Not reported
Not reported
Week 24 DBP,high,n=15, 0, 0, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
5
Not reported
Not reported
Not reported
Not reported
Week 24, DBP,low,n=15, 0, 0, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
FU Week 1, DBP,high,n=5, 0, 0, 13
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
2
Not reported
Not reported
Not reported
Not reported
FU Week 1, DBP,low,n=5, 0, 0, 13
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
FU Week 2, DBP,high,n=5, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
2
Not reported
Not reported
Not reported
Not reported
FU Week 2, DBP,low,n=5, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
FU Week 3, DBP,high,n=5, 0, 0, 14
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
2
Not reported
Not reported
Not reported
Not reported
FU Week 3, DBP,low,n=5, 0, 0, 14
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
0
Not reported
Not reported
Not reported
Not reported
FU Week 4, DBP,high,n=3, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
7
Not reported
Not reported
Not reported
Not reported
FU Week 4, DBP,low,n=3, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
5
Not reported
Not reported
Not reported
Not reported
Screening, SBP, high, n=15, 20, 41, 40
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
10
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
10
Not reported
Not reported
Not reported
Not reported
Screening, SBP, low, n=15, 20, 41, 40
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
2
Not reported
Not reported
Not reported
Not reported
Day 1, SBP,high,n=14, 18, 38, 59
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
5
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
9
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
14
Not reported
Not reported
Not reported
Not reported
Day 1, SBP,low,n=14, 18, 38, 59
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
4
Not reported
Not reported
Not reported
Not reported
Week 1, SBP,high,n=14, 19, 42, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
14
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
18
Not reported
Not reported
Not reported
Not reported
Week 1, SBP,low,n=14, 19, 42, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
8
Not reported
Not reported
Not reported
Not reported
Week 2, SBP,high,n=15, 20, 43, 62
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
15
Not reported
Not reported
Not reported
Not reported
Week 2, SBP,low,n=15, 20, 43, 62
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
6
Not reported
Not reported
Not reported
Not reported
Week 3, SBP,high,n=15, 21, 41, 60
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
12
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
17
Not reported
Not reported
Not reported
Not reported
Week 3, SBP,low,n=15, 21, 41, 60
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 4, SBP,high,n=15, 21, 42, 62
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
10
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
16
Not reported
Not reported
Not reported
Not reported
Week 4, SBP,low,n=15, 21, 42, 62
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
2
Not reported
Not reported
Not reported
Not reported
Week 5, SBP,high,n=15, 19, 40, 59
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
5
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
5
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
13
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
17
Not reported
Not reported
Not reported
Not reported
Week 5, SBP, low, n=15, 19, 40, 59
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 6, SBP,high,n=14, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
8
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
11
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
16
Not reported
Not reported
Not reported
Not reported
Week 6, SBP,low,n=14, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
5
Not reported
Not reported
Not reported
Not reported
Week 7, SBP,high,n=15, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
5
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
5
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
9
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
13
Not reported
Not reported
Not reported
Not reported
Week 7, SBP,low,n=15, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Part 2/ 3 (Eltrombopag Open-Label Period)
5
Not reported
Not reported
Not reported
Not reported
Week 8, SBP,high,n=15, 0, 0, 49
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
16
Not reported
Not reported
Not reported
Not reported
Week 8, SBP,low,n=15, 0, 0, 49
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
4
Not reported
Not reported
Not reported
Not reported
Week 9, SBP,high,n=15, 0, 0, 45
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
15
Not reported
Not reported
Not reported
Not reported
Week 9, SBP,low,n=15, 0, 0, 45
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
2
Not reported
Not reported
Not reported
Not reported
Week 10, SBP,high,n=15, 0, 0, 40
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
10
Not reported
Not reported
Not reported
Not reported
Week 10, SBP,low,n=15, 0, 0, 40
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 11, SBP,high,n=13, 0, 0, 41
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
9
Not reported
Not reported
Not reported
Not reported
Week 11, SBP,low,n=13, 0, 0, 41
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
2
Not reported
Not reported
Not reported
Not reported
Week 12, SBP,high,n=13, 0, 0, 42
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
10
Not reported
Not reported
Not reported
Not reported
Week 12, SBP,low,n=13, 0, 0, 42
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 13, SBP,high,n=12, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
8
Not reported
Not reported
Not reported
Not reported
Week 13, SBP,low,n=12, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 14, SBP,high,n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
10
Not reported
Not reported
Not reported
Not reported
Week 14, SBP,low,n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Week 15, SBP,high,n=11, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
9
Not reported
Not reported
Not reported
Not reported
Week 15, SBP,low,n=11, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
Week 16 SBP,high,n=12, 0, 0, 39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
5
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
14
Not reported
Not reported
Not reported
Not reported
Week 16, SBP,low,n=12, 0, 0, 39
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
Week 17, SBP,high,n=5, 0, 0, 29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
9
Not reported
Not reported
Not reported
Not reported
Week 17, SBP,low,n=5, 0, 0, 29
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
0
Not reported
Not reported
Not reported
Not reported
Week 18, SBP,high,n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
10
Not reported
Not reported
Not reported
Not reported
Week 18, SBP,low,n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
Week 19, SBP,high,n=5, 0, 0, 34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
9
Not reported
Not reported
Not reported
Not reported
Week 19, SBP,low,n=5, 0, 0, 34
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
2
Not reported
Not reported
Not reported
Not reported
Week 20, SBP,high,n=13, 0, 0, 33
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
6
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
10
Not reported
Not reported
Not reported
Not reported
Week 20, SBP,low,n=13, 0, 0, 33
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
Week 21, SBP,high,n=10, 0, 0, 17
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
0
Not reported
Not reported
Not reported
Not reported
Week 21, SBP,low,n=10, 0, 0, 17
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
0
Not reported
Not reported
Not reported
Not reported
Week 22, SBP,high,n=11, 0, 0, 23
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
8
Not reported
Not reported
Not reported
Not reported
Week 22, SBP,low,n=11, 0, 0, 23
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
0
Not reported
Not reported
Not reported
Not reported
Week 23, SBP,high,n=11, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
6
Not reported
Not reported
Not reported
Not reported
Week 23, SBP,low,n=11, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
Week 24, SBP,high,n=15, 0, 0, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
4
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
19
Not reported
Not reported
Not reported
Not reported
Week 24, SBP, low, n=15, 0, 0, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
2
Not reported
Not reported
Not reported
Not reported
FU Week 1, SBP, high,n=5, 0, 0, 13
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
4
Not reported
Not reported
Not reported
Not reported
FU Week 1, SBP, low,n=5, 0, 0, 13
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
0
Not reported
Not reported
Not reported
Not reported
FU Week 2, SBP, high,n=5, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
FU Week 2, SBP, low,n=5, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
FU Week 3, SBP, high,n=5, 0, 0, 14
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
4
Not reported
Not reported
Not reported
Not reported
FU Week 3, SBP, low,n=5, 0, 0, 14
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
0
Not reported
Not reported
Not reported
Not reported
FU Week 4, SBP, high,n=3, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
10
Not reported
Not reported
Not reported
Not reported
FU Week 4, SBP,low,n=3, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Placebo
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - Eltrombopag
NA
Not reported
Not reported
Not reported
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
4
group Id
OG002
value
3
group Id
OG003
value
3
title
Screening, DBP, high, n=15 ,20 ,41 ,40
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
group Id
OG002
value
6
group Id
OG003
value
5
title
Screening, DBP, low, n=15, 20, 41, 40
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
4
group Id
OG002
value
3
group Id
OG003
value
7
title
Day 1, DBP, high, n=14, 18, 38, 59
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
3
group Id
OG003
value
4
title
Day 1, DBP, low, n=14, 18, 38, 59
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
group Id
OG002
value
4
group Id
OG003
value
5
title
Week 1, DBP, high, n=14, 19, 42, 63
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
4
group Id
OG003
value
5
title
Week 1, DBP, low, n=14, 19, 42, 63
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
3
title
Week 2, DBP, high, n=15, 20, 42, 61
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
4
group Id
OG003
value
5
title
Week 2, DBP, low, n=15, 20, 42, 61
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
6
title
Week 3, DBP, high,n=15, 21, 41, 60
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
5
group Id
OG003
value
5
title
Week 3, DBP, low,n=15, 21, 41, 60
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
6
title
Week 4, DBP,high, n=15, 21, 42, 62
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
4
group Id
OG002
value
3
group Id
OG003
value
5
title
Week 4, DBP,low, n=15, 21, 42, 62
denoms
counts
group Id
OG000
value
15
group Id
OG001
value
21
group Id
OG002
value
44
group Id
OG003
value
65
units
Participants
description
Vital sign assessments included systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements that were measured before any blood draw at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, at each Follow-up week (Week 1-4) and the maximum post- Baseline (BL) visit. BL is defined as the value obtained on Day 1of treatment. The maximum post-BL visit (MPB) included any scheduled and unscheduled post-BL assessment. Reference ranges (RR) for SBP (mmHg) (Lower limit of normal, normal, Upper limit of normal) for Cohort 1: \<85, 85-115, \>115; for Cohort 2: \<85, 85-120,\>120; and Cohort 3: \<95, 95-135, \>135. RR for DBP (mmHg) for Cohort 1: \<45, 45-70,\>70; for Cohort 2: \<50, 50-75, \>75; and Cohort 3: \<55, 55-85, \>85.
groups
description
Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For cohort 2 starting dose was based on the body weight. Par with a bodyweight of \<27 kg received 12.5 mg QD, par with a body weight of \>=27 kg received 25 mg QD; par of east Asian ancestry with a body weight \<27 kg received 12.5 mg QD, and with a body weight of \>=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
id
OG000
title
Part 1 Eltrombopag Dose-Finding Period
description
Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag matching placebo for 7 weeks.
id
OG001
title
Part 2 Randomized Period - Placebo
description
Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of \<27 kg received 25 mg QD, and par with a body weight of \>=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD, and with a body weight of \>=27 kg received 25 mg QD. For Cohort 3, the starting dose was 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
id
OG002
title
Part 2 Randomized Period - Eltrombopag
description
Par aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3: 1 to 5 years), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
id
OG003
title
Part 2/ 3 (Eltrombopag Open-Label Period)
param Type
NUMBER
population Description
Safety 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 Safety Population.
reporting Status
POSTED
time Frame
From Baseline through Study Week 35
title
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3