Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and 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
NUMBER
Unit
Participants
Interval / dispersion
Not reported
Time frame
Post-Baseline from Week 1 through Follow-up up to Study Week 35
What was measured
Clinical chemistry parameters included: aspartate amino transferase (AST, reference range \[RR\]: 0-38 International Units per Liter \[IU/L\]), alkaline phosphatase (ALP: RR: 50 - 375 IU/L), total bilirubin (RR: 3.42 - 22.23 micromoles \[umol\]/L), albumin grams \[g/L\], alanine amino transferase (ALT, RR: 5-30 IU/L), prothrombin international normalized ratio (PT INR, RR-0.9 - 1.2), activated partial thromboplastin time (APTT, RR: 24.2 - 32.9 seconds), glucose (RR: 4.107- 6.55018 millimoles \[mmol\]/L), potassium (3 - 5 mmol/L), and sodium (135 - 143 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated clinical chemistry data outside of the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-Baseline assessment
Analysis population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,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 1 (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 body weight 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.
Part 2 (Randomized Period) -Placebo
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 matching placebo for 7 weeks.
Part 2 (Randomized Period) - Eltrombopag
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 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of \<27 kg received 25 mg QD, and par with a body weight of \>=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of \<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 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
Part 2/3 (Eltrombopag Open-Label Period)
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), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
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 (Dose-Finding Period)
15
Part 2 (Randomized Period) -Placebo
21
Part 2 (Randomized Period) - Eltrombopag
44
Part 2/3 (Eltrombopag Open-Label Period)
65
Reported measurements
AST high, n=15, 21, 44, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
5
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
17
Not reported
Not reported
Not reported
Not reported
AST low, n=15, 21, 44, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
7
Not reported
Not reported
Not reported
Not reported
ALT, high, n= 15, 21, 44, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
14
Not reported
Not reported
Not reported
Not reported
ALT, low, n= 15, 21, 44, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
11
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, high, n=15, 21, 44, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
5
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
9
Not reported
Not reported
Not reported
Not reported
Total Bilirubin, low, n=15, 21, 44, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
6
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
16
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
31
Not reported
Not reported
Not reported
Not reported
Direct Bilirubin, high, n=10, 16, 34, 55
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
0
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
Direct Bilirubin, low, n=10, 16, 34, 55
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
8
Not reported
Not reported
Not reported
Not reported
Albumin, high, n=15, 21, 24, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
9
Not reported
Not reported
Not reported
Not reported
Albumin, low, n=15, 21, 24, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
5
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
11
Not reported
Not reported
Not reported
Not reported
ALP, high, n=15, 21, 24, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
6
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
13
Not reported
Not reported
Not reported
Not reported
ALP, low, n=15, 21, 24, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
11
Not reported
Not reported
Not reported
Not reported
PT INR, high, n=15, 20, 42, 64
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
12
Not reported
Not reported
Not reported
Not reported
PT INR, low, n=15, 20, 42, 64
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
0
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
1
Not reported
Not reported
Not reported
Not reported
PT, high, n=13, 20, 36, 61
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
5
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
5
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
24
Not reported
Not reported
Not reported
Not reported
PT, low, n=13, 20, 36, 61
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
0
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
0
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
3
Not reported
Not reported
Not reported
Not reported
PTT, high, n=15, 21, 41, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
11
Not reported
Not reported
Not reported
Not reported
PTT, low, n=15, 21, 41, 63
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
0
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
1
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
9
Not reported
Not reported
Not reported
Not reported
Glucose, high, n=15, 21, 44, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
5
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
5
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
7
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
27
Not reported
Not reported
Not reported
Not reported
Glucose, low, n=15, 21, 44, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
6
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
16
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
29
Not reported
Not reported
Not reported
Not reported
Potassium, high, n=15, 21, 44, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
7
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
0
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
3
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
9
Not reported
Not reported
Not reported
Not reported
Potassium, low, n=15, 21, 44, 65,
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
3
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
4
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
8
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
14
Not reported
Not reported
Not reported
Not reported
Sodium, high, n=15, 21, 44, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
2
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
6
Not reported
Not reported
Not reported
Not reported
Sodium, low, n=15, 21, 44, 65
Values in Participants · Interval/dispersion: Not reported
Group
Value
Spread
Lower
Upper
Comment
Part 1 (Dose-Finding Period)
2
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) -Placebo
1
Not reported
Not reported
Not reported
Not reported
Part 2 (Randomized Period) - Eltrombopag
4
Not reported
Not reported
Not reported
Not reported
Part 2/3 (Eltrombopag Open-Label Period)
9
Not reported
Not reported
Not reported
Not reported
Complete source fields
classes
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
4
group Id
OG002
value
7
group Id
OG003
value
17
title
AST high, n=15, 21, 44, 65
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
1
group Id
OG002
value
3
group Id
OG003
value
7
title
AST low, n=15, 21, 44, 65
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
3
group Id
OG003
value
14
title
ALT, high, n= 15, 21, 44, 65
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
3
group Id
OG002
value
4
group Id
OG003
value
11
title
ALT, low, n= 15, 21, 44, 65
categories
measurements
group Id
OG000
value
5
group Id
OG001
value
2
group Id
OG002
value
2
group Id
OG003
value
9
title
Total Bilirubin, high, n=15, 21, 44, 65
categories
measurements
group Id
OG000
value
6
group Id
OG001
value
0
group Id
OG002
value
16
group Id
OG003
value
31
title
Total Bilirubin, low, n=15, 21, 44, 65
categories
measurements
group Id
OG000
value
0
group Id
OG001
value
1
group Id
OG002
value
1
group Id
OG003
value
3
title
Direct Bilirubin, high, n=10, 16, 34, 55
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
0
group Id
OG002
value
6
group Id
OG003
value
8
title
Direct Bilirubin, low, n=10, 16, 34, 55
categories
measurements
group Id
OG000
value
3
group Id
OG001
value
3
group Id
OG002
value
2
group Id
OG003
value
9
title
Albumin, high, n=15, 21, 24, 65
categories
measurements
group Id
OG000
value
1
group Id
OG001
value
3
group Id
OG002
value
5
group Id
OG003
value
11
title
Albumin, low, n=15, 21, 24, 65
categories
measurements
group Id
OG000
value
4
group Id
OG001
value
1
group Id
OG002
value
6
group Id
OG003
value
13
title
ALP, high, n=15, 21, 24, 65
categories
measurements
group Id
OG000
value
2
group Id
OG001
value
2
group Id
OG002
value
4
group Id
OG003
value
11
title
ALP, low, n=15, 21, 24, 65
denoms
counts
group Id
OG000
value
15
group Id
OG001
value
21
group Id
OG002
value
44
group Id
OG003
value
65
units
Participants
description
Clinical chemistry parameters included: aspartate amino transferase (AST, reference range \[RR\]: 0-38 International Units per Liter \[IU/L\]), alkaline phosphatase (ALP: RR: 50 - 375 IU/L), total bilirubin (RR: 3.42 - 22.23 micromoles \[umol\]/L), albumin grams \[g/L\], alanine amino transferase (ALT, RR: 5-30 IU/L), prothrombin international normalized ratio (PT INR, RR-0.9 - 1.2), activated partial thromboplastin time (APTT, RR: 24.2 - 32.9 seconds), glucose (RR: 4.107- 6.55018 millimoles \[mmol\]/L), potassium (3 - 5 mmol/L), and sodium (135 - 143 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated clinical chemistry data outside of the reference range (with high and low) any time post-Baseline are presented. Anytime post-Baseline assesments included any scheduled and unscheduled post-Baseline assessment
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 body weight 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 (Dose-Finding Period)
description
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 matching placebo for 7 weeks.
id
OG001
title
Part 2 (Randomized Period) -Placebo
description
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 7 weeks. The starting dose for Cohort 1 was 37.5 mg QD. For Cohort 2, starting dose was based on the body weight. Par with a body weight of \<27 kg received 25 mg QD, and par with a body weight of \>=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of \<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 1.5 mg/kg QD and 0.8 mg/kg/day for par of East Asian ancestry. The maximum dose allowed was 2mg/kg and could not exceed 75 mg daily. For all par, individual dose titration was allowed based upon platelet response.
id
OG002
title
Part 2 (Randomized Period) - Eltrombopag
description
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), completing Part 2 of the study received an Open -Label treatment of eltrombopag administered as a tablet or dry powder for oral suspension in Part 2/3. Par who received eltrombopag during the Randomized Period continued on the same dose, unless adjustments were warranted according to the dosing guidelines, for 17 additional weeks (for a total of 24 weeks of treatment). Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2, and received a total of 24 weeks of eltrombopag treatment.
id
OG003
title
Part 2/3 (Eltrombopag Open-Label Period)
param Type
NUMBER
population Description
Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,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
Post-Baseline from Week 1 through Follow-up up to Study Week 35
title
Number of Participants With the Indicated Clinical Chemistry Parameter Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Triangle