Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During Part 1
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 up to Week 13 of Part 1
What was measured
Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: Grade 0 (G0), none; Grade 1 (G1), mild; Grade 2 (G2), moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling. Clinical chemistry parameters included: aspartate amino transferase (AST), alkaline phosphatase (ALP), total bilirubin, albumin, alanine amino transferase (ALT), prothrombin international normalized ratio (PT INR), activated partial thromboplastin time (APTT), and creatinine. The Baseline value is defined as the value taken at 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 Baseline. The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during Part 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).
Groups in this outcome
Part 1 (Randmoized Period)-Placebo
In Part 1, participants aged between 6 and 17 years with a body weight \<27 kg received placebo 37.5 mg QD, and those with a body weight \>=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
Part 1 (Randomized Period) - Eltrombopag
In Part 1, participants 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; 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 1 (Randmoized Period)-Placebo
29
Part 1 (Randomized Period) - Eltrombopag
63
Reported measurements
AST, G0, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
26
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
50
Not reported
Not reported
Not reported
Not reported
AST, G1, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
12
Not reported
Not reported
Not reported
Not reported
AST, G2, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
AST, G3, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
AST, G4, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
ALT, G0, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
27
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
52
Not reported
Not reported
Not reported
Not reported
ALT, G1, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
ALT, G2, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
ALT, G3, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
ALT, G4, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, G0, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
29
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
60
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, G1, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, G2, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, G3, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, G4, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Albumin, G0, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
29
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
63
Not reported
Not reported
Not reported
Not reported
Albumin, G1, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Albumin, G2, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Albumin, G3, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Albumin, G4, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
ALP, G0, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
28
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
47
Not reported
Not reported
Not reported
Not reported
ALP, G1, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
16
Not reported
Not reported
Not reported
Not reported
ALP, G2, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
ALP, G3, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
ALP, G4, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
PT INR, G0, n=27, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
26
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
57
Not reported
Not reported
Not reported
Not reported
PT INR, G1, n=27, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
PT INR, G2, n=27, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
PT INR, G3, n=27, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
PT INR, G4, n=27, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
APTT, G0 n=27, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
13
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
24
Not reported
Not reported
Not reported
Not reported
APTT, G1, n=27, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
13
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
32
Not reported
Not reported
Not reported
Not reported
APTT, G2, n=27, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
APTT, G3, n=27, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
APTT, G4, n=27, 58
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Creatinine, G0, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
22
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
47
Not reported
Not reported
Not reported
Not reported
Creatinine, G1, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
15
Not reported
Not reported
Not reported
Not reported
Creatinine, G2, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Creatinine, G3, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Creatinine, G4, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Randmoized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
50
title
AST, G0, n=29, 63
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
12
title
AST, G1, n=29, 63
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
AST, G2, n=29, 63
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
AST, G3, n=29, 63
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
AST, G4, n=29, 63
categories
measurements
group Id
OG000
value
27
group Id
OG001
value
52
title
ALT, G0, n=29, 63
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
6
title
ALT, G1, n=29, 63
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
title
ALT, G2, n=29, 63
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
ALT, G3, n=29, 63
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
ALT, G4, n=29, 63
categories
measurements
group Id
OG000
value
29
group Id
OG001
value
60
title
Total Bilirubin, G0, n=29, 63
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
3
title
Total Bilirubin, G1, n=29, 63
denoms
counts
group Id
OG000
value
29
group Id
OG001
value
63
units
Participants
description
Clinical chemistry parameters were summarized according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0: Grade 0 (G0), none; Grade 1 (G1), mild; Grade 2 (G2), moderate; Grade 3 (G3), severe; Grade 4 (G4), life-threatening or disabling. Clinical chemistry parameters included: aspartate amino transferase (AST), alkaline phosphatase (ALP), total bilirubin, albumin, alanine amino transferase (ALT), prothrombin international normalized ratio (PT INR), activated partial thromboplastin time (APTT), and creatinine. The Baseline value is defined as the value taken at 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 Baseline. The maximum post-Baseline toxicity grade includes any scheduled or unscheduled post-Baseline assessment during Part 1.
groups
description
In Part 1, participants aged between 6 and 17 years with a body weight \<27 kg received placebo 37.5 mg QD, and those with a body weight \>=27 kg received placebo 50 mg QD. Participants of East Asian ancestry received a starting dose of placebo 25 mg QD. Participants aged between 1 and 5 years received placebo 1.2 mg/kg QD; participants of East Asian ancestry received a starting dose of placebo 0.8 mg/kg/day.
id
OG000
title
Part 1 (Randmoized Period)-Placebo
description
In Part 1, participants 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; participants of East Asian ancestry received a starting dose of eltrombopag 0.8 mg/kg/day.
id
OG001
title
Part 1 (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).
reporting Status
POSTED
time Frame
From Baseline up to Week 13 of Part 1
title
Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Clinical Chemistry Parameters at Any Time Post-Baseline During Part 1
Triangle