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NCT00908037 · OUTCOME

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

GroupSource count
Part 1 Eltrombopag Dose-Finding Period15
Part 2 Randomized Period - Placebo21
Part 2 Randomized Period - Eltrombopag44
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
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Screening, DBP, low, n=15, 20, 41, 40
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag6Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)5Not reportedNot reportedNot reportedNot reported
Day 1, DBP, high, n=14, 18, 38, 59
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)7Not reportedNot reportedNot reportedNot reported
Day 1, DBP, low, n=14, 18, 38, 59
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)4Not reportedNot reportedNot reportedNot reported
Week 1, DBP, high, n=14, 19, 42, 63
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag4Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)5Not reportedNot reportedNot reportedNot reported
Week 1, DBP, low, n=14, 19, 42, 63
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag4Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)5Not reportedNot reportedNot reportedNot reported
Week 2, DBP, high, n=15, 20, 42, 61
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 2, DBP, low, n=15, 20, 42, 61
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag4Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)5Not reportedNot reportedNot reportedNot reported
Week 3, DBP, high,n=15, 21, 41, 60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)6Not reportedNot reportedNot reportedNot reported
Week 3, DBP, low,n=15, 21, 41, 60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag5Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)5Not reportedNot reportedNot reportedNot reported
Week 4, DBP,high, n=15, 21, 42, 62
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)6Not reportedNot reportedNot reportedNot reported
Week 4, DBP,low, n=15, 21, 42, 62
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)5Not reportedNot reportedNot reportedNot reported
Week 5, DBP, high, n=15, 19, 40, 59
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag4Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)8Not reportedNot reportedNot reportedNot reported
Week 5, DBP, low, n=15, 19, 40, 59
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag5Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)5Not reportedNot reportedNot reportedNot reported
Week 6, DBP, high, n=14, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)5Not reportedNot reportedNot reportedNot reported
Week 6, DBP, low, n=14, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)4Not reportedNot reportedNot reportedNot reported
Week 7, DBP, high, n=15, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag6Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)7Not reportedNot reportedNot reportedNot reported
Week 7, DBP, low, n=15, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)4Not reportedNot reportedNot reportedNot reported
Week 8, DBP,high,n=15, 0, 0, 49
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)4Not reportedNot reportedNot reportedNot reported
Week 8, DBP,low,n=15, 0, 0, 49
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)6Not reportedNot reportedNot reportedNot reported
Week 9, DBP, high, n=15, 0, 0, 45
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)4Not reportedNot reportedNot reportedNot reported
Week 9, DBP, low, n=15, 0, 0, 45
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)6Not reportedNot reportedNot reportedNot reported
Week 10, DBP, high, n=15, 0, 0, 40
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)6Not reportedNot reportedNot reportedNot reported
Week 10, DBP, low, n=15, 0, 0, 40
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 11, DBP, high, n=13, 0, 0, 41
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)4Not reportedNot reportedNot reportedNot reported
Week 11, DBP, low, n=13, 0, 0, 41
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 12, DBP, high, n=13, 0, 0, 42
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)5Not reportedNot reportedNot reportedNot reported
Week 12, DBP, low, n=13, 0, 0, 42
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 13, DBP, high, n=12, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)0Not reportedNot reportedNot reportedNot reported
Week 13, DBP, low, n=12, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)5Not reportedNot reportedNot reportedNot reported
Week 14, DBP, high, n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 14, DBP, low, n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 15, DBP, high, n=11, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 15, DBP, low, n=11, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)0Not reportedNot reportedNot reportedNot reported
Week 16, DBP,high,n=12, 0, 0, 39
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)2Not reportedNot reportedNot reportedNot reported
Week 16, DBP,low,n=12, 0, 0, 39
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 17, DBP,high,n=5, 0, 0, 29
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)2Not reportedNot reportedNot reportedNot reported
Week 17, DBP,low,n=5, 0, 0, 29
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
Week 18, DBP,high,n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 18, DBP,low,n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
Week 19, DBP,high,n=5, 0, 0, 34
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
Week 19, DBP,low,n=5, 0, 0, 34
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)2Not reportedNot reportedNot reportedNot reported
Week 20, DBP,high,n=13, 0, 0, 33
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)0Not reportedNot reportedNot reportedNot reported
Week 20, DBP,low,n=13, 0, 0, 33
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
Week 21, DBP,high,n=10, 0, 0, 17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
Week 21, DBP,low,n=10, 0, 0, 17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
Week 22, DBP,high,n=11, 0, 0, 23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
Week 22, DBP,low,n=11, 0, 0, 23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)0Not reportedNot reportedNot reportedNot reported
Week 23, DBP,high,n=11, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
Week 23, DBP,low,n=11, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)2Not reportedNot reportedNot reportedNot reported
Week 24 DBP,high,n=15, 0, 0, 58
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)5Not reportedNot reportedNot reportedNot reported
Week 24, DBP,low,n=15, 0, 0, 58
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
FU Week 1, DBP,high,n=5, 0, 0, 13
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)2Not reportedNot reportedNot reportedNot reported
FU Week 1, DBP,low,n=5, 0, 0, 13
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
FU Week 2, DBP,high,n=5, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)2Not reportedNot reportedNot reportedNot reported
FU Week 2, DBP,low,n=5, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
FU Week 3, DBP,high,n=5, 0, 0, 14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)2Not reportedNot reportedNot reportedNot reported
FU Week 3, DBP,low,n=5, 0, 0, 14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)0Not reportedNot reportedNot reportedNot reported
FU Week 4, DBP,high,n=3, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)7Not reportedNot reportedNot reportedNot reported
FU Week 4, DBP,low,n=3, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)5Not reportedNot reportedNot reportedNot reported
Screening, SBP, high, n=15, 20, 41, 40
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag10Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)10Not reportedNot reportedNot reportedNot reported
Screening, SBP, low, n=15, 20, 41, 40
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)2Not reportedNot reportedNot reportedNot reported
Day 1, SBP,high,n=14, 18, 38, 59
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo5Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag9Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)14Not reportedNot reportedNot reportedNot reported
Day 1, SBP,low,n=14, 18, 38, 59
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag4Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)4Not reportedNot reportedNot reportedNot reported
Week 1, SBP,high,n=14, 19, 42, 63
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo6Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag14Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)18Not reportedNot reportedNot reportedNot reported
Week 1, SBP,low,n=14, 19, 42, 63
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag4Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)8Not reportedNot reportedNot reportedNot reported
Week 2, SBP,high,n=15, 20, 43, 62
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo7Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag7Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)15Not reportedNot reportedNot reportedNot reported
Week 2, SBP,low,n=15, 20, 43, 62
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag5Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)6Not reportedNot reportedNot reportedNot reported
Week 3, SBP,high,n=15, 21, 41, 60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag12Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)17Not reportedNot reportedNot reportedNot reported
Week 3, SBP,low,n=15, 21, 41, 60
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 4, SBP,high,n=15, 21, 42, 62
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo6Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag10Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)16Not reportedNot reportedNot reportedNot reported
Week 4, SBP,low,n=15, 21, 42, 62
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)2Not reportedNot reportedNot reportedNot reported
Week 5, SBP,high,n=15, 19, 40, 59
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period5Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo5Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag13Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)17Not reportedNot reportedNot reportedNot reported
Week 5, SBP, low, n=15, 19, 40, 59
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 6, SBP,high,n=14, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo8Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag11Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)16Not reportedNot reportedNot reportedNot reported
Week 6, SBP,low,n=14, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag3Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)5Not reportedNot reportedNot reportedNot reported
Week 7, SBP,high,n=15, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period5Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo5Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag9Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)13Not reportedNot reportedNot reportedNot reported
Week 7, SBP,low,n=15, 21, 42, 58
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Placebo0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - Eltrombopag2Not reportedNot reportedNot reportedNot reported
Part 2/ 3 (Eltrombopag Open-Label Period)5Not reportedNot reportedNot reportedNot reported
Week 8, SBP,high,n=15, 0, 0, 49
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)16Not reportedNot reportedNot reportedNot reported
Week 8, SBP,low,n=15, 0, 0, 49
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)4Not reportedNot reportedNot reportedNot reported
Week 9, SBP,high,n=15, 0, 0, 45
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)15Not reportedNot reportedNot reportedNot reported
Week 9, SBP,low,n=15, 0, 0, 45
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)2Not reportedNot reportedNot reportedNot reported
Week 10, SBP,high,n=15, 0, 0, 40
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)10Not reportedNot reportedNot reportedNot reported
Week 10, SBP,low,n=15, 0, 0, 40
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 11, SBP,high,n=13, 0, 0, 41
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)9Not reportedNot reportedNot reportedNot reported
Week 11, SBP,low,n=13, 0, 0, 41
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)2Not reportedNot reportedNot reportedNot reported
Week 12, SBP,high,n=13, 0, 0, 42
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)10Not reportedNot reportedNot reportedNot reported
Week 12, SBP,low,n=13, 0, 0, 42
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 13, SBP,high,n=12, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)8Not reportedNot reportedNot reportedNot reported
Week 13, SBP,low,n=12, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 14, SBP,high,n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)10Not reportedNot reportedNot reportedNot reported
Week 14, SBP,low,n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Week 15, SBP,high,n=11, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)9Not reportedNot reportedNot reportedNot reported
Week 15, SBP,low,n=11, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
Week 16 SBP,high,n=12, 0, 0, 39
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period5Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)14Not reportedNot reportedNot reportedNot reported
Week 16, SBP,low,n=12, 0, 0, 39
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
Week 17, SBP,high,n=5, 0, 0, 29
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)9Not reportedNot reportedNot reportedNot reported
Week 17, SBP,low,n=5, 0, 0, 29
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)0Not reportedNot reportedNot reportedNot reported
Week 18, SBP,high,n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)10Not reportedNot reportedNot reportedNot reported
Week 18, SBP,low,n=9, 0, 0, 32
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
Week 19, SBP,high,n=5, 0, 0, 34
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)9Not reportedNot reportedNot reportedNot reported
Week 19, SBP,low,n=5, 0, 0, 34
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)2Not reportedNot reportedNot reportedNot reported
Week 20, SBP,high,n=13, 0, 0, 33
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period6Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)10Not reportedNot reportedNot reportedNot reported
Week 20, SBP,low,n=13, 0, 0, 33
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
Week 21, SBP,high,n=10, 0, 0, 17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)0Not reportedNot reportedNot reportedNot reported
Week 21, SBP,low,n=10, 0, 0, 17
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)0Not reportedNot reportedNot reportedNot reported
Week 22, SBP,high,n=11, 0, 0, 23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)8Not reportedNot reportedNot reportedNot reported
Week 22, SBP,low,n=11, 0, 0, 23
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period3Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)0Not reportedNot reportedNot reportedNot reported
Week 23, SBP,high,n=11, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)6Not reportedNot reportedNot reportedNot reported
Week 23, SBP,low,n=11, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)1Not reportedNot reportedNot reportedNot reported
Week 24, SBP,high,n=15, 0, 0, 58
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period4Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)19Not reportedNot reportedNot reportedNot reported
Week 24, SBP, low, n=15, 0, 0, 58
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)2Not reportedNot reportedNot reportedNot reported
FU Week 1, SBP, high,n=5, 0, 0, 13
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)4Not reportedNot reportedNot reportedNot reported
FU Week 1, SBP, low,n=5, 0, 0, 13
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)0Not reportedNot reportedNot reportedNot reported
FU Week 2, SBP, high,n=5, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period2Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
FU Week 2, SBP, low,n=5, 0, 0, 21
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
FU Week 3, SBP, high,n=5, 0, 0, 14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)4Not reportedNot reportedNot reportedNot reported
FU Week 3, SBP, low,n=5, 0, 0, 14
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period0Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)0Not reportedNot reportedNot reportedNot reported
FU Week 4, SBP, high,n=3, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)10Not reportedNot reportedNot reportedNot reported
FU Week 4, SBP,low,n=3, 0, 0, 31
Values in Participants · Interval/dispersion: Not reported
GroupValueSpreadLowerUpperComment
Part 1 Eltrombopag Dose-Finding Period1Not reportedNot reportedNot reportedNot reported
Part 2 Randomized Period - PlaceboNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2 Randomized Period - EltrombopagNANot reportedNot reportedNot reportedPart 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
Part 2/ 3 (Eltrombopag Open-Label Period)3Not reportedNot reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        3
    title
    Screening, DBP, high, n=15 ,20 ,41 ,40
  2. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        6
      4. group Id
        OG003
        value
        5
    title
    Screening, DBP, low, n=15, 20, 41, 40
  3. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        7
    title
    Day 1, DBP, high, n=14, 18, 38, 59
  4. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        4
    title
    Day 1, DBP, low, n=14, 18, 38, 59
  5. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        5
    title
    Week 1, DBP, high, n=14, 19, 42, 63
  6. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        1
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        5
    title
    Week 1, DBP, low, n=14, 19, 42, 63
  7. categories
    1. measurements
      1. group Id
        OG000
        value
        3
      2. group Id
        OG001
        value
        2
      3. group Id
        OG002
        value
        2
      4. group Id
        OG003
        value
        3
    title
    Week 2, DBP, high, n=15, 20, 42, 61
  8. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        4
      4. group Id
        OG003
        value
        5
    title
    Week 2, DBP, low, n=15, 20, 42, 61
  9. categories
    1. measurements
      1. group Id
        OG000
        value
        1
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        6
    title
    Week 3, DBP, high,n=15, 21, 41, 60
  10. categories
    1. measurements
      1. group Id
        OG000
        value
        2
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        5
      4. group Id
        OG003
        value
        5
    title
    Week 3, DBP, low,n=15, 21, 41, 60
  11. categories
    1. measurements
      1. group Id
        OG000
        value
        0
      2. group Id
        OG001
        value
        3
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        6
    title
    Week 4, DBP,high, n=15, 21, 42, 62
  12. categories
    1. measurements
      1. group Id
        OG000
        value
        4
      2. group Id
        OG001
        value
        4
      3. group Id
        OG002
        value
        3
      4. group Id
        OG003
        value
        5
    title
    Week 4, DBP,low, n=15, 21, 42, 62
denoms
  1. counts
    1. group Id
      OG000
      value
      15
    2. group Id
      OG001
      value
      21
    3. group Id
      OG002
      value
      44
    4. 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
  1. 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
  2. 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
  3. 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
  4. 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
type
SECONDARY
unit Of Measure
Participants

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

Preserved source evidence · Not medical advice