Number of Participants With the Indicated Maximum Toxicity Grade for the Indicated Hematology 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
Hematology parameters were summarized according to the NCI CTCAE, version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: leukocytes, neutrophils, hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), and lymphocytes (decreased). The Baseline value is defined as the value taken at Day 1 or, if missing, the latest non-missing Screening value. 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(Randomized 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(Randomized Period)-Placebo
29
Part 1 (Randomized Period) - Eltrombopag
63
Reported measurements
Leukocytes, G0, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized Period)-Placebo
23
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
50
Not reported
Not reported
Not reported
Not reported
Leukocytes, G1, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized Period)-Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
11
Not reported
Not reported
Not reported
Not reported
Leukocytes, G2, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Leukocytes, G3, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Leukocytes, G4, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Neutrophils G0, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Neutrophils G1, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized Period)-Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Neutrophils G2, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
Neutrophils G3, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized Period)-Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Neutrophils G4, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Hemoglobin (increased), G0, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized Period)-Placebo
26
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
49
Not reported
Not reported
Not reported
Not reported
Hemoglobin (increased), G1, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Hemoglobin (increased), G2, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Hemoglobin (increased), G3, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Hemoglobin (increased), G4, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Hemoglobin (anemia), G0, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized Period)-Placebo
20
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
42
Not reported
Not reported
Not reported
Not reported
Hemoglobin (anemia), G1, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized Period)-Placebo
7
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
17
Not reported
Not reported
Not reported
Not reported
Hemoglobin (anemia), G2, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized Period)-Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Hemoglobin (anemia), G3, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized Period)-Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Hemoglobin (anemia), G4, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Lymphocytes (increased), G0, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized Period)-Placebo
17
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
37
Not reported
Not reported
Not reported
Not reported
Lymphocytes (increased), G1, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Lymphocytes (increased), G2, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized Period)-Placebo
12
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
26
Not reported
Not reported
Not reported
Not reported
Lymphocytes (increased), G3, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Lymphocytes (increased), G4, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Lymphocytes (decreased), G0, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized Period)-Placebo
25
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
48
Not reported
Not reported
Not reported
Not reported
Lymphocytes (decreased), G1, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized Period)-Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 1 (Randomized Period) - Eltrombopag
13
Not reported
Not reported
Not reported
Not reported
Lymphocytes (decreased), G2, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Lymphocytes (decreased), G3, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
Lymphocytes (decreased), G4, n=29, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1(Randomized 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
23
group Id
OG001
value
50
title
Leukocytes, G0, n=29, 63
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
11
title
Leukocytes, G1, n=29, 63
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
0
title
Leukocytes, G2, n=29, 63
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Leukocytes, G3, n=29, 63
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
title
Leukocytes, G4, n=29, 63
categories
measurements
group Id
OG000
value
27
group Id
OG001
value
52
title
Neutrophils G0, n=29, 63
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
title
Neutrophils G1, n=29, 63
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
6
title
Neutrophils G2, n=29, 63
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
title
Neutrophils G3, n=29, 63
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
2
title
Neutrophils G4, n=29, 63
categories
measurements
group Id
OG000
value
26
group Id
OG001
value
49
title
Hemoglobin (increased), G0, n=29, 63
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
12
title
Hemoglobin (increased), G1, n=29, 63
denoms
counts
group Id
OG000
value
29
group Id
OG001
value
63
units
Participants
description
Hematology parameters were summarized according to the NCI CTCAE, version 4.0: G0, none; G1, mild; G2, moderate; G3, severe; G4, life-threatening or disabling. Hematology parameters included: leukocytes, neutrophils, hemoglobin (increased), hemoglobin (anemia), lymphocytes (increased), and lymphocytes (decreased). The Baseline value is defined as the value taken at Day 1 or, if missing, the latest non-missing Screening value. 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(Randomized 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 Hematology Parameters at Any Time Post-Baseline During Part 1
Triangle