Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP) · Source last updated 2018-10-12
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Measure
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Baseline and Week 7 of Part 2
What was measured
Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 7 (W7). The Baseline value was the measurement taken at Day 1.
Analysis population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=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 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 QD 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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Part 2 Randomized Period - Placebo
21
Part 2 Randomized Period - Eltrombopag
44
Reported measurements
UP, MS, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UP, NR, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
UP, Neg, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
UP, Trace, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UP, 1+, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UP, 2+, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UP, 3+, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UP, 4+, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, MS, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, NR, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
UG, Neg, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
UG, normal, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, 5, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, 15(1+), BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, 30(2+), BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, 60(3+), BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, 110(4+), BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UK, MS, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UK, NR, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
UK, Neg, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
8
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
UK, Trace(5), BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UK, Small(15), BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UK, Moderate(40), BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UK, Large(80), BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UK, Large(160), BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UOB, MS, BL, n=9, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
UOB, NR, BL, n=9, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
UOB, Neg, BL, n=9, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
UOB, 1+, BL,n=9, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
UOB, 2+, BL,n=9, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UOB, 3+, BL, n=9, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UOB, Non haemolysed trace, BL,n=9, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UOB, haemolysed trace, BL, n=9, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, MS, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, NR, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
pH, normal result, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, Neg, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, 5, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
pH, 5.5, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
pH, 6, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
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
pH, 6.5, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
pH, 7, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, 7.5,BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
pH, 8, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, 8.5, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, 9, BL, n=10, 9
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UP, MS, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UP, NR, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UP, Neg, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
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
UP, Trace, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UP, 1+, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UP, 2+, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UP, 3+, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UP, 4+, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, MS, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, NR, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, Neg, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
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
UG, normal, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, 5, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, 15(1+), W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, 30(2+), W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, 60(3+), W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UG, 110(4+), W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UK, MS, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UK, NR, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UK, Neg, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
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
UK, Trace(5), W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UK, Small(15), W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UK, Moderate(40), W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UK, Large(80), W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UK, Large(160), W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UOB, MS, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UOB, NR, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UOB, Neg, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
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
UOB, 1+, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UOB, 2+, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UOB, 3+, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UOB, Non haemolysed trace, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
UOB, haemolysed trace, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, MS, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, NR, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, normal result, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, Neg, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, 5, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, 5.5, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, 6, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
pH, 6.5, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
pH, 7, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
pH, 7.5, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, 8, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, 8.5, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
pH, 9, W7, n=2, 3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 Randomized Period - Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 Randomized Period - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
UP, MS, BL, n=10, 9
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
UP, NR, BL, n=10, 9
categories
measurements
group Id
OG000
value
7
group Id
OG001
value
8
title
UP, Neg, BL, n=10, 9
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
UP, Trace, BL, n=10, 9
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
UP, 1+, BL, n=10, 9
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
UP, 2+, BL, n=10, 9
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
UP, 3+, BL, n=10, 9
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
UP, 4+, BL, n=10, 9
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
UG, MS, BL, n=10, 9
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
UG, NR, BL, n=10, 9
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
8
title
UG, Neg, BL, n=10, 9
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
0
title
UG, normal, BL, n=10, 9
denoms
counts
group Id
OG000
value
21
group Id
OG001
value
44
units
Participants
description
Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 7 (W7). The Baseline value was the measurement taken at Day 1.
groups
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 QD for 7 weeks.
id
OG000
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
OG001
title
Part 2 Randomized Period - Eltrombopag
param Type
NUMBER
population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=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
Baseline and Week 7 of Part 2
title
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
Triangle