Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
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 24 of Part 1
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 24 (W24). 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 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.
Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.
Analysis denominator · Participants
Group
Source count
Part 1 Eltrombopag Dose-Finding Period
15
Reported measurements
UP, MS, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
UP, NR, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UP, Neg, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UP, Trace, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
UP, 1+, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UP, 2+, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UP, 3+, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UP, 4+, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, MS, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, NR, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, Neg, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
UG, normal, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, 5, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, 15(1+), BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, 30(2+), BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, 60(3+), BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, 110(4+), BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UK, MS, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UK, NR, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UK, Neg, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
UK, Trace(5), BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UK, Small(15), BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UK, Moderate(40), BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UK, Large(80), BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UK, Large(160), BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UOB, MS, BL,n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
UOB, NR, BL,n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UOB, Neg, BL,n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
UOB, 1+, BL,n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UOB, 2+, BL,n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UOB, 3+, BL,n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UOB, Non haemolysed trace, BL,n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UOB, haemolysed trace, BL,n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, MS, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, NR, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, normal result, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, Neg, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, 5, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, 5.5, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, 6, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, 6.5, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
pH, 7, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, 7.5,BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
pH, 8, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
pH, 8.5, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, 9, BL, n=3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UP, MS, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UP, NR, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UP, Neg, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
UP, Trace, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
UP, 1+, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UP, 2+, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UP, 3+, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UP, 4+, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, MS, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, NR, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, Neg, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
4
Not reported
Not reported
Not reported
Not reported
UG, normal, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, 5, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, 15(1+), W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, 30(2+), W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, 60(3+), W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UG, 110(4+), W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UK, MS, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UK, NR, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UK, Neg, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
UK, Trace(5), W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
1
Not reported
Not reported
Not reported
Not reported
UK, Small(15), W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UK, Moderate(40), W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UK, Large(80), W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UK, Large(160), W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UOB, MS, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UOB, NR, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UOB, Neg, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
3
Not reported
Not reported
Not reported
Not reported
UOB, 1+, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UOB, 2+, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UOB, 3+, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UOB, Non haemolysed trace, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
UOB, haemolysed trace, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, MS, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, NR, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, normal result, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, Neg, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, 5, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, 5.5, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, 6, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
pH, 6.5, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
2
Not reported
Not reported
Not reported
Not reported
pH, 7, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, 7.5,W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, 8, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, 8.5, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
pH, 9, W24, n=4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 Eltrombopag Dose-Finding Period
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
1
title
UP, MS, BL, n=3
categories
measurements
group Id
OG000
value
0
title
UP, NR, BL, n=3
categories
measurements
group Id
OG000
value
0
title
UP, Neg, BL, n=3
categories
measurements
group Id
OG000
value
2
title
UP, Trace, BL, n=3
categories
measurements
group Id
OG000
value
0
title
UP, 1+, BL, n=3
categories
measurements
group Id
OG000
value
0
title
UP, 2+, BL, n=3
categories
measurements
group Id
OG000
value
0
title
UP, 3+, BL, n=3
categories
measurements
group Id
OG000
value
0
title
UP, 4+, BL, n=3
categories
measurements
group Id
OG000
value
0
title
UG, MS, BL, n=3
categories
measurements
group Id
OG000
value
0
title
UG, NR, BL, n=3
categories
measurements
group Id
OG000
value
3
title
UG, Neg, BL, n=3
categories
measurements
group Id
OG000
value
0
title
UG, normal, BL, n=3
denoms
counts
group Id
OG000
value
15
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 24 (W24). The Baseline value was the measurement taken at Day 1.
groups
description
Participants (par) aged between 1 and 17 years (Cohort 1 age group: 12 to 17 years, Cohort 2: 6 to 11 years and Cohort 3:1 to 5 years) received eltrombopag for 24 weeks. The starting dose for Cohort 1 was 25 mg, and par of East Asian ancestry received 12.5mg QD. For Cohort 2 starting dose was based on the body weight. Par with a bodyweight of \<27 kg received 12.5 mg QD, par with a body weight of \>=27 kg received 25 mg QD; par of East Asian ancestry with a body weight \<27 kg received 12.5 mg QD, and with a body weight of \>=27 kg received 25 mg QD. For Cohort 3, the starting dose was 0.7 mg/kg QD and 0.5 mg/kg/day for par of East Asian ancestry and the dose calculations were based on the body weight. The maximum dose allowed for all Cohorts was 75mg daily. For all par, individual dose titration was allowed based upon platelet response.
id
OG000
title
Part 1 Eltrombopag Dose-Finding Period
param Type
NUMBER
population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=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 24 of Part 1
title
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
Triangle