Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
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
MEAN
Unit
Breaths per minute
Interval / dispersion
Standard Deviation
Time frame
From Week 1 to Follow-up Week 4 of Part 2/3 up to Study Week 35
What was measured
Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.
Analysis population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,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 2/3 (Eltrombopag Period) Cohort 1
All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2/3 (Eltrombopag Period) Cohort 2
All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of \<=27 kg received 25 mg QD and participants with a body weight of \>=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2/3 (Eltrombopag Period) Cohort 3
All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration 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 2/3 (Eltrombopag Period) Cohort 1
24
Part 2/3 (Eltrombopag Period) Cohort 2
26
Part 2/3 (Eltrombopag Period) Cohort 3
15
Reported measurements
Screening, n=16, 14, 10
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
18.5
1.75
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
21.2
6.57
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
21.5
2.56
Not reported
Not reported
Not reported
Day 1 , n=21, 21, 15
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
19.2
2.57
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
2.12
7.74
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
21.7
4.76
Not reported
Not reported
Not reported
Week 1, n=24, 25, 14
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
19.1
1.74
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
20.4
3.93
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
25.1
7.63
Not reported
Not reported
Not reported
Week 2, n=22, 24, 13
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
19.4
2.56
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
21.8
6.85
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
25.2
10.83
Not reported
Not reported
Not reported
Week 3, n=24, 23, 12
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
18.8
1.73
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
21.2
4.40
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
24.0
6.09
Not reported
Not reported
Not reported
Week 4, n=23, 23, 13
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
19.0
2.59
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
20.9
3.82
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
24.3
6.37
Not reported
Not reported
Not reported
Week 5, n=23, 23, 11
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
18.9
2.13
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
19.8
3.19
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
26.9
12.91
Not reported
Not reported
Not reported
Week 6, n=23, 22, 11
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
19.3
2.30
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
20.6
4.11
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
23.3
4.92
Not reported
Not reported
Not reported
Week 7, n=22, 25, 11
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
18.8
1.99
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
20.1
4.46
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
22.4
4.60
Not reported
Not reported
Not reported
Week 8, n=19, 19, 10
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
19.2
2.32
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
23.4
6.23
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
22.0
1.79
Not reported
Not reported
Not reported
Week 9, n=17, 16, 12
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
19.5
2.96
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
22.0
3.95
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
22.5
4.48
Not reported
Not reported
Not reported
Week 10, n=16, 13, 11
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
18.7
2.27
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
22.8
3.83
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
23.3
6.83
Not reported
Not reported
Not reported
Week 11, n=15, 13, 12
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
18.9
1.28
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
22.8
3.11
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
22.2
5.29
Not reported
Not reported
Not reported
Week 12, n=17, 16, 9
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
18.6
1.90
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
22.2
3.76
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
23.6
4.98
Not reported
Not reported
Not reported
Week 13, n=11, 13, 8
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
19.3
1.56
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
23.4
7.68
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
21.0
2.62
Not reported
Not reported
Not reported
Week 14, n=13, 11, 7
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
18.7
2.98
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
19.9
5.49
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
23.4
4.86
Not reported
Not reported
Not reported
Week 15, n=12, 13, 5
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
18.7
1.76
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
21.1
2.53
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
24.4
8.76
Not reported
Not reported
Not reported
Week 16, n=16, 14, 8
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
18.6
1.26
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
22.9
7.97
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
24.3
6.88
Not reported
Not reported
Not reported
Week 17, n=13, 10, 5
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
19.0
2.08
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
22.4
6.45
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
25.2
9.65
Not reported
Not reported
Not reported
Week 18, n=16, 12, 4
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
19.1
3.79
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
22.0
4.53
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
29.0
10.52
Not reported
Not reported
Not reported
Week 19, n=14, 13, 6
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
18.1
1.49
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
24.5
19.33
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
24.0
6.45
Not reported
Not reported
Not reported
Week 20, n=13, 13, 7
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
17.4
1.94
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
20.9
3.52
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
33.00
16.77
Not reported
Not reported
Not reported
Week 21, n=4, 10, 3
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
18.8
3.40
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
20.2
3.55
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
28.0
10.58
Not reported
Not reported
Not reported
Week 22, n=11, 7, 5
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
19.7
2.94
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
19.1
2.79
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
26.0
4.90
Not reported
Not reported
Not reported
Week 23, n=8, 7, 6
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
20.4
2.72
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
21.1
3.24
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
23.7
5.13
Not reported
Not reported
Not reported
Week 24, n=22, 23, 11
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
19.1
2.03
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
20.2
3.11
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
23.8
5.47
Not reported
Not reported
Not reported
FU Week 1, n=6, 6, 3
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
18.8
1.60
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
20.0
3.41
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
26.0
10.39
Not reported
Not reported
Not reported
FU Week 2, n=6, 5, 7
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
18.7
1.63
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
20.8
4.15
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
22.2
4.02
Not reported
Not reported
Not reported
FU Week 3, n=6, 4, 4
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
19.0
1.67
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
23.0
4.16
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
24.8
5.50
Not reported
Not reported
Not reported
FU Week 4, n=10, 12, 7
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
19.4
0.97
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
20.8
1.86
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
21.0
3.74
Not reported
Not reported
Not reported
MPB, n=24, 26, 15
Values in Breaths per minute · Interval/dispersion: Standard Deviation
Group
Value
Spread
Lower
Upper
Comment
Part 2/3 (Eltrombopag Period) Cohort 1
23.0
2.78
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 2
27.7
13.00
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Period) Cohort 3
27.7
11.54
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
spread
1.75
value
18.5
group Id
OG001
spread
6.57
value
21.2
group Id
OG002
spread
2.56
value
21.5
title
Screening, n=16, 14, 10
categories
measurements
group Id
OG000
spread
2.57
value
19.2
group Id
OG001
spread
7.74
value
2.12
group Id
OG002
spread
4.76
value
21.7
title
Day 1 , n=21, 21, 15
categories
measurements
group Id
OG000
spread
1.74
value
19.1
group Id
OG001
spread
3.93
value
20.4
group Id
OG002
spread
7.63
value
25.1
title
Week 1, n=24, 25, 14
categories
measurements
group Id
OG000
spread
2.56
value
19.4
group Id
OG001
spread
6.85
value
21.8
group Id
OG002
spread
10.83
value
25.2
title
Week 2, n=22, 24, 13
categories
measurements
group Id
OG000
spread
1.73
value
18.8
group Id
OG001
spread
4.40
value
21.2
group Id
OG002
spread
6.09
value
24.0
title
Week 3, n=24, 23, 12
categories
measurements
group Id
OG000
spread
2.59
value
19.0
group Id
OG001
spread
3.82
value
20.9
group Id
OG002
spread
6.37
value
24.3
title
Week 4, n=23, 23, 13
categories
measurements
group Id
OG000
spread
2.13
value
18.9
group Id
OG001
spread
3.19
value
19.8
group Id
OG002
spread
12.91
value
26.9
title
Week 5, n=23, 23, 11
categories
measurements
group Id
OG000
spread
2.30
value
19.3
group Id
OG001
spread
4.11
value
20.6
group Id
OG002
spread
4.92
value
23.3
title
Week 6, n=23, 22, 11
categories
measurements
group Id
OG000
spread
1.99
value
18.8
group Id
OG001
spread
4.46
value
20.1
group Id
OG002
spread
4.60
value
22.4
title
Week 7, n=22, 25, 11
categories
measurements
group Id
OG000
spread
2.32
value
19.2
group Id
OG001
spread
6.23
value
23.4
group Id
OG002
spread
1.79
value
22.0
title
Week 8, n=19, 19, 10
categories
measurements
group Id
OG000
spread
2.96
value
19.5
group Id
OG001
spread
3.95
value
22.0
group Id
OG002
spread
4.48
value
22.5
title
Week 9, n=17, 16, 12
categories
measurements
group Id
OG000
spread
2.27
value
18.7
group Id
OG001
spread
3.83
value
22.8
group Id
OG002
spread
6.83
value
23.3
title
Week 10, n=16, 13, 11
denoms
counts
group Id
OG000
value
24
group Id
OG001
value
26
group Id
OG002
value
15
units
Participants
description
Respiratory rate was measured at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, and at each Follow-up Weeks 1-4. Baseline is defined as the value obtained on Day 1 of treatment. The maximum post-Baseline visit included any scheduled and unscheduled post-Baseline assessment. Participants randomized to receive eltrombopag for 7 weeks in Part 2 continued receiving eltrombopag for an additional 17 weeks in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 24. Participants randomized to receive placebo for 7 weeks in Part 2, received 24 weeks of eltrombopag in Part 2/3 (for a total of 24 weeks of treatment) up to Study Week 31.
dispersion Type
Standard Deviation
groups
description
All participants aged between 12 and 17 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag starting at 37.5 mg QD up to Week 31 of the study. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
id
OG000
title
Part 2/3 (Eltrombopag Period) Cohort 1
description
All participants aged between 6 and 11 years and completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet in Part 2/3. Participants with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Participants with a body weight of \<=27 kg received 25 mg QD and participants with a body weight of \>=27 kg QD received 50 mg QD. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
id
OG001
title
Part 2/3 (Eltrombopag Period) Cohort 2
description
All participants aged between 1 and 5 years and completing Part 2 of the study received an Open-Label treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Participants who received placebo in Part 2 received 24 weeks of treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Participants of East Asian ancestry received 0.8 mg/kg/day. Participants who received 7 weeks of eltrombopag treatment in Part 2 received an additional 17 weeks of treatment to complete a total of 24 weeks continuing at the same dosage at the end of Part 2. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
id
OG002
title
Part 2/3 (Eltrombopag Period) Cohort 3
param Type
MEAN
population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,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
From Week 1 to Follow-up Week 4 of Part 2/3 up to Study Week 35
title
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Triangle