Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During Part 2
Study of a New Medication for Childhood Chronic Immune Thrombocytopenia (ITP), a Blood Disorder of Low Platelet Counts That Can Lead to Bruising Easily, Bleeding Gums, and/or Bleeding Inside the Body. · Source last updated 2015-03-10
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 (BL) of Part 2 through Follow-up
What was measured
Clinical chemistry parameters were summarized according to the NCI CTCAE, version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: AST, ALP, total bilirubin, albumin, ALT, and creatinine. For participants randomized to Placebo in Part 1, the BL value for Part 2 is defined as the value taken at Week 13 of Part 1. For serum creatinine, the value taken at Week 13 of Part 1 will be used as BL. For participants randomized to Eltrombopag in Part 1, the BL value is defined as the value taken on Day 1 or, if missing, the latest non-missing Screening value. For serum creatinine, due to the variations in creatinine, the average of the Screening and the Day 1 values will be used as BL. For participants who do not have both a Screening and Day 1 value, the Screening or Day 1 value will be used as BL. The maximum post-BL toxicity grade includes any scheduled or unscheduled post-BL assessment.
Analysis population: Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.
Groups in this outcome
Part 2 (Open-Label Period) - Eltrombopag
Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
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 (Open-Label Period) - Eltrombopag
87
Reported measurements
AST, G0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
63
Not reported
Not reported
Not reported
Not reported
AST, G1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
21
Not reported
Not reported
Not reported
Not reported
AST, G2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
AST, G3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
AST, G4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
ALT, G0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
67
Not reported
Not reported
Not reported
Not reported
ALT, G1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
14
Not reported
Not reported
Not reported
Not reported
ALT, G2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
ALT, G3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
ALT, G4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, G0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
80
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, G1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, G2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, G3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, G4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Albumin, G0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
85
Not reported
Not reported
Not reported
Not reported
Albumin, G1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Albumin, G2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Albumin, G3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Albumin, G4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
ALP, G0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
67
Not reported
Not reported
Not reported
Not reported
ALP, G1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
20
Not reported
Not reported
Not reported
Not reported
ALP, G2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
ALP, G3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
ALP, G4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Creatinine, G0
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
72
Not reported
Not reported
Not reported
Not reported
Creatinine, G1
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
14
Not reported
Not reported
Not reported
Not reported
Creatinine, G2
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Creatinine, G3
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Creatinine, G4
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 2 (Open-Label Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
63
title
AST, G0
categories
measurements
group Id
OG000
value
21
title
AST, G1
categories
measurements
group Id
OG000
value
1
title
AST, G2
categories
measurements
group Id
OG000
value
2
title
AST, G3
categories
measurements
group Id
OG000
value
0
title
AST, G4
categories
measurements
group Id
OG000
value
67
title
ALT, G0
categories
measurements
group Id
OG000
value
14
title
ALT, G1
categories
measurements
group Id
OG000
value
3
title
ALT, G2
categories
measurements
group Id
OG000
value
3
title
ALT, G3
categories
measurements
group Id
OG000
value
0
title
ALT, G4
categories
measurements
group Id
OG000
value
80
title
Total Bilirubin, G0
categories
measurements
group Id
OG000
value
4
title
Total Bilirubin, G1
denoms
counts
group Id
OG000
value
87
units
Participants
description
Clinical chemistry parameters were summarized according to the NCI CTCAE, version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Clinical chemistry parameters included: AST, ALP, total bilirubin, albumin, ALT, and creatinine. For participants randomized to Placebo in Part 1, the BL value for Part 2 is defined as the value taken at Week 13 of Part 1. For serum creatinine, the value taken at Week 13 of Part 1 will be used as BL. For participants randomized to Eltrombopag in Part 1, the BL value is defined as the value taken on Day 1 or, if missing, the latest non-missing Screening value. For serum creatinine, due to the variations in creatinine, the average of the Screening and the Day 1 values will be used as BL. For participants who do not have both a Screening and Day 1 value, the Screening or Day 1 value will be used as BL. The maximum post-BL toxicity grade includes any scheduled or unscheduled post-BL assessment.
groups
description
Participants who received eltrombopag in Part 1 continued on the same dose in Part 2 unless adjustments were warranted according to the dosing guidelines. Participants who received placebo in Part 1 received Eltrombopag as per age criteria as follows: aged between 6 and 17 years with a body weight \<27 kg received eltrombopag 37.5 mg QD, and those with a body weight \>=27 kg received eltrombopag 50 mg QD. Participants of East Asian ancestry received a starting dose of eltrombopag 25 mg QD. Participants aged between 1 and 5 years received eltrombopag 1.2 mg/kg QD and; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
id
OG000
title
Part 2 (Open-Label Period) - Eltrombopag
param Type
NUMBER
population Description
Safety Population. Only those participants who entered into Part 2 (Open-label eltrombopag-only phase) were analyzed.
reporting Status
POSTED
time Frame
From Baseline (BL) of Part 2 through Follow-up
title
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During Part 2
Triangle