Trial Outcomes & Findings for Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP) (NCT NCT00908037)

NCT ID: NCT00908037

Last Updated: 2018-10-12

Results Overview

Participants who achieved a platelet count \>=50 Gi/L at least once between Day 8 and Day 43 (first 6 weeks of Part 2) in the absense of rescue treatment were reported. A 95% confidence interval was calculated by the exact binomial method.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

82 participants

Primary outcome timeframe

From Day 8 up to Day 43 of Part 2

Results posted on

2018-10-12

Participant Flow

Pediatric participants (par.) meeting eligibility criteria were enrolled into 3 cohorts depending upon age. Cohort 1 enrolled participants who were between 12 and 17 years old, Cohort 2 enrolled participants who were between 6 and 11 years old, and Cohort 3 enrolled participants who were between 1 and 5 years old.

15 par. were randomized to a 24-Week (Wk) Open-Label (OL) eltrombopag Dose-Finding period (pd) (Part 1) then did not continue. 67 par. were randomized to a 7-Wk Double-Blind placebo-controlled pd (Part 2), followed by a 24-Wk OL eltrombopag-only pd (Part 2/3) and a 4-Wk Follow-Up pd.

Participant milestones

Participant milestones
Measure
Part 1 (Dose-Finding Period) Cohort 1
Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 1 (Dose-Finding Period) Cohort 2
Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of \<27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of \>=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 1 (Dose-Finding Period) Cohort 3
Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 1-Placebo
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2/3 (Eltrombopag Open-Label 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 Open-Label 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 Open- Label 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.
Part1 (24 Week Dose-Finding Period)
STARTED
5
5
5
0
0
0
0
0
0
0
0
0
Part1 (24 Week Dose-Finding Period)
COMPLETED
5
5
5
0
0
0
0
0
0
0
0
0
Part1 (24 Week Dose-Finding Period)
NOT COMPLETED
0
0
0
0
0
0
0
0
0
0
0
0
Part 2 (7 Week Randomized Period)
STARTED
0
0
0
8
16
9
19
5
10
0
0
0
Part 2 (7 Week Randomized Period)
COMPLETED
0
0
0
7
13
9
15
5
5
0
0
0
Part 2 (7 Week Randomized Period)
NOT COMPLETED
0
0
0
1
3
0
4
0
5
0
0
0
Part 2/3(Eltrombopag Open-Label Period)
STARTED
0
0
0
0
0
0
0
0
0
24
28
15
Part 2/3(Eltrombopag Open-Label Period)
COMPLETED
0
0
0
0
0
0
0
0
0
21
24
12
Part 2/3(Eltrombopag Open-Label Period)
NOT COMPLETED
0
0
0
0
0
0
0
0
0
3
4
3

Reasons for withdrawal

Reasons for withdrawal
Measure
Part 1 (Dose-Finding Period) Cohort 1
Participants aged between 12 and 17 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was 25 milligrams (mg), once daily (QD). The participants of East Asian ancestry began at 12.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 1 (Dose-Finding Period) Cohort 2
Participants aged between 6 and 11 years received a 24-week Open-Label treatment of eltrombopag administered as a tablet. The starting dose of eltrombopag was based on the body weight. Participants with a weight of \<27 kilograms (kg) received 12.5 mg QD (approximately 0.5 - 0.7 mg/kg QD) and participants with a weight of \>=27 kg received 25 mg QD (approximately 0.5 - 0.8 mg/kg QD). The maximum dose allowed was 2 mg/kg and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 1 (Dose-Finding Period) Cohort 3
Participants aged between 1 and 5 years received a 24-week Open-Label treatment of eltrombopag administered as a dry powder for oral suspension. The starting dose of eltrombopag was 0.7 mg/kg QD. Participants of East Asian ancestry began at 0.5 mg/kg/day. The maximum dose allowed was 2 mg/kg, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 1-Placebo
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2/3 (Eltrombopag Open-Label 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 Open-Label 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 Open- Label 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.
Part 2 (7 Week Randomized Period)
Protocol Violation
0
0
0
0
1
0
3
0
1
0
0
0
Part 2 (7 Week Randomized Period)
Lost to Follow-up
0
0
0
0
2
0
0
0
4
0
0
0
Part 2 (7 Week Randomized Period)
Withdrawal by parent/ guardian
0
0
0
1
0
0
1
0
0
0
0
0
Part 2/3(Eltrombopag Open-Label Period)
Lack of Efficacy
0
0
0
0
0
0
0
0
0
0
0
1
Part 2/3(Eltrombopag Open-Label Period)
Lost to Follow-up
0
0
0
0
0
0
0
0
0
1
0
2
Part 2/3(Eltrombopag Open-Label Period)
Withdrawal by parent/guardian
0
0
0
0
0
0
0
0
0
1
0
0
Part 2/3(Eltrombopag Open-Label Period)
Adverse Event
0
0
0
0
0
0
0
0
0
0
2
0
Part 2/3(Eltrombopag Open-Label Period)
Physician Decision
0
0
0
0
0
0
0
0
0
1
0
0
Part 2/3(Eltrombopag Open-Label Period)
Randomized but did not receive treatment
0
0
0
0
0
0
0
0
0
0
2
0

Baseline Characteristics

Efficacy and Safety Study of Eltrombopag in Pediatric Patients With Thrombocytopenia From Chronic Idiopathic Thrombocytopenic Purpura (ITP)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Part 1 Eltrombopag Dose-Finding Period
n=15 Participants
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 bodyweight 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) Cohort 1-Placebo
n=8 Participants
Par aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag in Part 2/3 starting at 37.5 mg QD up to Week 31 of the study. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=16 Participants
Par aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par 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 par enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=9 Participants
Par aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of treatment of eltrombopag based on body weight up to Week 31 of the study. Par with a body weight of \&lt;=27 kg received 25 mg QD and par with a body weight of \&gt;=27 kg QD received 50 mg QD. The maximum dose allowed was 75 mg daily. All par enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
n=19 Participants
Par aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, par with a weight of \&lt;27 kg received 25 mg QD and par with a weight of \&gt;=27 kg received 50 mg QD. Par of East Asian ancestry with a body weight of \&lt;27 kg received 12.5 mg QD and par with a weight of \&gt;=27 kg received 25 mg QD. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a tablet in Part 2/3. Par with difficulty swallowing a tablet in Part 2 were administered eltrombopag as a dry powder for oral suspension in Part 2/3. Par 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 par enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
n=5 Participants
Par aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par who received placebo in Part 2 received 24 weeks of OL treatment of eltrombopag up to Week 31 of the study at 1.5 mg/kg QD. Par of East Asian ancestry received 0.8 mg/kg/day. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
n=10 Participants
Par aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Par of East Asian ancestry began at 0.8 mg/kg/day. All par completing Part 2 of the study received an OL treatment of eltrombopag administered as a dry powder for oral suspension in Part 2/3. Par 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 par enrolled in the study underwent individual dose titration based upon platelet response.
Total
n=82 Participants
Total of all reporting groups
Age, Continuous
9.1 Years
STANDARD_DEVIATION 4.61 • n=5 Participants
14.6 Years
STANDARD_DEVIATION 1.69 • n=7 Participants
13.7 Years
STANDARD_DEVIATION 1.58 • n=5 Participants
8.6 Years
STANDARD_DEVIATION 2.24 • n=4 Participants
8.2 Years
STANDARD_DEVIATION 1.87 • n=21 Participants
3.6 Years
STANDARD_DEVIATION 1.34 • n=8 Participants
3.3 Years
STANDARD_DEVIATION 1.34 • n=8 Participants
9.3 Years
STANDARD_DEVIATION 4.49 • n=24 Participants
Sex: Female, Male
Female
8 Participants
n=5 Participants
3 Participants
n=7 Participants
8 Participants
n=5 Participants
8 Participants
n=4 Participants
14 Participants
n=21 Participants
2 Participants
n=8 Participants
5 Participants
n=8 Participants
48 Participants
n=24 Participants
Sex: Female, Male
Male
7 Participants
n=5 Participants
5 Participants
n=7 Participants
8 Participants
n=5 Participants
1 Participants
n=4 Participants
5 Participants
n=21 Participants
3 Participants
n=8 Participants
5 Participants
n=8 Participants
34 Participants
n=24 Participants
Race/Ethnicity, Customized
African American/African Heritage
2 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
3 Participants
n=24 Participants
Race/Ethnicity, Customized
Asian - Japanese/East Asian Heritage
2 Participants
n=5 Participants
1 Participants
n=7 Participants
0 Participants
n=5 Participants
1 Participants
n=4 Participants
1 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
6 Participants
n=24 Participants
Race/Ethnicity, Customized
White - White/Caucasian/European
9 Participants
n=5 Participants
7 Participants
n=7 Participants
14 Participants
n=5 Participants
8 Participants
n=4 Participants
17 Participants
n=21 Participants
5 Participants
n=8 Participants
7 Participants
n=8 Participants
67 Participants
n=24 Participants
Race/Ethnicity, Customized
Unknown
1 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
0 Participants
n=8 Participants
1 Participants
n=24 Participants
Race/Ethnicity, Customized
White - Arabic/North African Heritage
0 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
2 Participants
n=24 Participants
Race/Ethnicity, Customized
Mixed Race
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
0 Participants
n=4 Participants
0 Participants
n=21 Participants
0 Participants
n=8 Participants
1 Participants
n=8 Participants
3 Participants
n=24 Participants

PRIMARY outcome

Timeframe: From Day 8 up to Day 43 of Part 2

Population: Intent-to-Treat (ITT) Population: all enrolled participants during Part 2. The ITT Population was the primary population used for assessing efficacy. Only evaluable participants were considered for analysis where participants with a Baseline platelet count \>10Gi/L was considered as evaluable.

Participants who achieved a platelet count \>=50 Gi/L at least once between Day 8 and Day 43 (first 6 weeks of Part 2) in the absense of rescue treatment were reported. A 95% confidence interval was calculated by the exact binomial method.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=8 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=16 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=9 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
n=17 Participants
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
n=5 Participants
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
n=10 Participants
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Percentage of Participants Achieving a Platelet Count >=50 Giga Cells Per Liter (Gi/L) at Least Once, Between Day 8 and Day 43 (Weeks 1 to 6) of the Randomized Period of the Study (Part 2)
0 Percentage of Participants
62.5 Percentage of Participants
33.3 Percentage of Participants
63.2 Percentage of Participants
80.0 Percentage of Participants
60.0 Percentage of Participants

SECONDARY outcome

Timeframe: Between Day 15 and Day 43 of Part 2

Population: Intent-to-Treat (ITT) Population, only those participants enrolled in Part 2 of this study were analyzed.

Sustained platelet response between the treatment groups was assessed by determining the number of participants who achieved a platelet count \>=50 Gi/L during treatment with eltrombopag in \>= 60% of assessments between Day 15 and Day 43 in the absence of rescue treatment were reported here.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=22 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=45 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Percentage of Participants Achieving Platelet Counts >=50Gi/L During Treatment With Eltrombopag in >= 60% of Assessments Between Day 15 and Day 43 (Weeks 2 Through 6) of the Randomized Treatment Period (Part 2)
0 Percentage of Participants
35.6 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Day 43 of Part 2

Population: ITT Population. Only participants during Part 2 with a value at baseline and post-baseline were considered for analysis

The weighted mean platelet count is defined as the area under the platelet-time curve divided by the duration of the treatment (12 weeks). Based on the Analysis of Covariance (ANCOVA) model, the weighted mean platelet count is the sum of the Baseline count plus the age cohort plus the treatment. Baseline was defined as the platelet count taken on Day 1 or within 48 hours prior to the first dose of treatment.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=21 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=43 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Weighted Mean Platelet Count
Baseline
12.2 Gi/L
Standard Deviation 8.59
15.5 Gi/L
Standard Deviation 8.03
Weighted Mean Platelet Count
Day 43
30.5 Gi/L
Standard Deviation 24.98
68 Gi/L
Standard Deviation 56.78

SECONDARY outcome

Timeframe: From Day 1 of treatment up to Week 24 of Part 1

Population: ITT Population only those participants enrolled during Part 1 were analyzed.

The percentage of participants achieving platelet counts \>=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment were reported.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=5 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Percentage of Participants Achieving Platelet Counts >=50Gi/L at Any Time During the 24 Weeks of Eltrombopag Dosing During Part 1.
80 Percentage of Participants
80 Percentage of Participants
60 Percentage of Participants

SECONDARY outcome

Timeframe: Part 2/3 up to Study Week 31

Population: ITT Population. Only evaluable participants were included for this analysis, where participants with a baseline platelet count \>10 Gi/L was considered as evaluable.

The percentage of participants achieving platelet counts \>=50Gi/L at least once at any time during the 24 weeks of eltrombopag treatment during Part 2/3 of the study were reported. Participants randmoized 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.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=24 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=26 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=15 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Percentage of Participants Achieving Platelet Counts >=50 Gi/L at Any Time During the 31 Weeks of Eltrombopag Treatment During Part 2/ 3.
75.0 Percentage of Participants
82.1 Percentage of Participants
86.7 Percentage of Participants

SECONDARY outcome

Timeframe: From Day 1 of treatment up to Study Week 31

Population: Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.

The area under the concentration-time curve over the dosing interval (AUC0-t) data was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. AUC(0-t) is defined as the area under the concentration-time curve over the dosing interval. From the final model, a single value of AUC(0-t) was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=29 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=30 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=19 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Population Pharmacokinetic (PK) Assessment for Eltrombopag for AUC(0-t) During Part 1, 2, and 2/3.
101 Microgram*hour per milliliter (ug*h/mL)
Interval 87.1 to 117.0
132 Microgram*hour per milliliter (ug*h/mL)
Interval 114.0 to 152.0
142 Microgram*hour per milliliter (ug*h/mL)
Interval 117.0 to 173.0

SECONDARY outcome

Timeframe: From Day 1 of treatment up to Study Week 31

Population: Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.

The maximum observed concentration (Cmax) and the concentration at the end of the dosing interval (Ct) data were collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. Doses were normalized to 50mg for comparison. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of Cmax and Ct were estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=29 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=30 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=19 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3.
Cmax
6.65 micrograms per milliliter (ug/mL)
Interval 5.87 to 7.53
9.19 micrograms per milliliter (ug/mL)
Interval 8.18 to 10.3
10.7 micrograms per milliliter (ug/mL)
Interval 9.24 to 12.5
Population Pharmacokinetic (PK) Assessments for Eltrombopag for Cmax and Ct During Part 1, 2, and 2/3.
Ct
2.42 micrograms per milliliter (ug/mL)
Interval 1.97 to 2.98
2.95 micrograms per milliliter (ug/mL)
Interval 2.41 to 3.6
2.91 micrograms per milliliter (ug/mL)
Interval 2.14 to 3.96

SECONDARY outcome

Timeframe: From Day 1 of treatment up to Study Week 31

Population: Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.

The time to maximum concentration (tmax) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of tmax was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=29 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=30 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=19 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Population Pharmacokinetic (PK) Assessments for Eltrombopag for Tmax During Part 1, 2, and 2/3
4.0 hour (hr)
Interval 2.0 to 6.0
4.0 hour (hr)
Interval 2.0 to 6.0
2.0 hour (hr)
Interval 2.0 to 4.0

SECONDARY outcome

Timeframe: From Day 1 of treatment up to Study Week 31

Population: Pharmacokinetic (PK) population. All subjects who had received at least one dose of the investigational product and provided a PK sample were included in this analysis.

The apparent plasma clearance following oral dosing of eltrombopag (CL/F) was collected to estimate primary model-based PK parameters. PK samples were collected within 3 hours prior to dosing and 2, 4, 6, 8 and 24 hours after dosing. PK samples were collected at each on-treatment visit during Part 1, Part 2, and Part 2/3. The concentration data were pooled across visits to identify population PK and variability parameter estimates and covariate effects. From the final model, a single value of CL/F was estimated for each subject, and geometric mean (95% CI) values are presented for each cohort for a 50mg dose.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=29 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=30 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=19 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Population Pharmacokinetic (PK) Assessments for Eltrombopag for CL/F During Part 1, 2, and 2/3
0.50 liter per hour (L/hr)
Interval 0.43 to 0.57
0.38 liter per hour (L/hr)
Interval 0.33 to 0.44
0.25 liter per hour (L/hr)
Interval 0.2 to 0.3

SECONDARY outcome

Timeframe: From Baseline through Week 7 of Part 2

Population: ITT Population, only those participants enrolled in Part 2 were analyzed. The number of participants used to compute the summary statistics reflect the ITT poplation through out the analyses during Part 2.

The maximum duration for which a participant continuously maintained a platelet count \>=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Excludes periods from initiation of rescue medication until platelet count falls to below 50Gi/L, irrespective of platelet count

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=8 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=16 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=9 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
n=19 Participants
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
n=5 Participants
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
n=10 Participants
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 7 Weeks of Eltrombopag Treatment in Part 2
0.0 Weeks
Interval 0.0 to 0.0
1.0 Weeks
Interval 0.0 to 5.0
0.0 Weeks
Interval 0.0 to 2.0
2.0 Weeks
Interval 0.0 to 6.0
1.0 Weeks
Interval 0.0 to 2.0
1.0 Weeks
Interval 0.0 to 6.0

SECONDARY outcome

Timeframe: From Baseline up to Study Week 31

Population: ITT Population only those participants enrolled in Part 2/3 were analyzed. The number of participants used to compute the summary statistics reflect the ITT poplation through out the analyses during Part 2/3.

The maximum duration for which a participant continuously maintained a platelet count \>=50 Gi/L in the absence of rescue treatment was calculated and summarized during the 24 weeks of eltrombopag treatment in Part 2/3. Participants with non-weekly assessments were assumed to have maintained a positive response for each week between two assessments that had positive responses. If a particpant achieved a positive response at an assessment and then achieved a negative response at the next assessment, then it was assumed that the participant had achieved a positive response for one day. Participants randmoized 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.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=24 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=28 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=15 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Maximum Duration for Which a Participant Continuously Maintained a Platelet Count of >=50 Gi/L During the 24 Weeks of Eltrombopag Treatment in Part 2/ 3
2.0 Weeks
Interval 0.0 to 23.0
8.0 Weeks
Interval 0.0 to 24.0
4.0 Weeks
Interval 0.0 to 24.0

SECONDARY outcome

Timeframe: From Baseline up to Week 24+ 1 day of Part 1

Population: ITT Population, only those participants enrolled during Part 1 were analyzed.

The participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 1 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants in Part 1, Baseline is defined as Day 1 of Part 1. A sustained reduction is defined as reduction for 4 weeks or more. An attempted red or dis is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 1 Day 1 to the last dose of study medication + 1 day.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=5 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1.
Taking an ITP medication at BL
0 Percentage of Participants
20.0 Percentage of Participants
0 Percentage of Participants
Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1.
Attempted red or dis
0 Percentage of Participants
100.0 Percentage of Participants
0 Percentage of Participants
Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1.
Permanent red or dis of all BL ITP mediation
0 Percentage of Participants
100.0 Percentage of Participants
0 Percentage of Participants
Percentage of Participants Who Reduced or Discontinued Baseline Concomitant Idiopathic Thrombocytopenic Purpura (ITP) Medications During the 24 Weeks of Eltrombopag Treatment During Part 1.
Permanent red or dis at least 1 BL ITP medcation
0 Percentage of Participants
100.0 Percentage of Participants
0 Percentage of Participants

SECONDARY outcome

Timeframe: From Baseline to the end of treatment up to Week 31 + 1 day of Part 2/3

Population: ITT Population, only those participants enrolled during Part 2/3 were analyzed.

Participants who discontinued (dis) or had a sustained reduction (red) of a Baseline (BL) ITP medication for at least one day during the period of Day 1 of Part 2/3 to the last dose of study medication +1 day are reported. The denominator is the number of subjects taking an ITP medication at baseline. For participants randomized to placebo in Part 2, BL is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, BL is defined as Day 1 of Part 2. A sustained reduction is defined as reduction for 4 weeks or more. An attempted reduction or discontinuation is a decrease in the dose or frequency from the BL dose or frequency of an ITP medication for at least one day during the period Part 2/3 Day 1 to the last dose of study medication + 1 day.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=24 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=28 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=15 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3
Taking an ITP medication at BL
25.0 Percentage of Participants
17.9 Percentage of Participants
13.3 Percentage of Participants
Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3
Attempted red or dis
66.7 Percentage of Participants
20.0 Percentage of Participants
100.0 Percentage of Participants
Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3
Permanent (perm) dis of all BL ITP medication(med)
16.7 Percentage of Participants
20.0 Percentage of Participants
50.0 Percentage of Participants
Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3
Perm dis at least 1 BL ITP med
33.3 Percentage of Participants
20.0 Percentage of Participants
50.0 Percentage of Participants
Percentage of Participants Who Reduced or Discontinued Baseline Concomitant ITP Medications During the 24 Weeks of Eltrombopag Treatment During Part 2/ 3
Perm dis all BL ITP med taken prior to Part 2/3
0 Percentage of Participants
40.0 Percentage of Participants
0 Percentage of Participants

SECONDARY outcome

Timeframe: From Baseline to the end of treatment up to Week 31 + 1 day of Part2/3

Population: ITT Population, only those participants enrolled during Part 2/3 were analyzed.

Rescue treatment was defined as either a new immune (idiopathic) thrombocytopenic purpura (ITP) medication, an increase in the dose of a concomitant ITP medication from Baseline, a platelet transfusion, or a splenectomy. For particpants randomized to placebo in Part 2, Baseline is defined as Week 7 of Part 2. For participants randomized to eltrombopag in Part 2, Baseline is defined as Day 1 of Part 2. Participants randmoized 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.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=24 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=28 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=15 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3
New ITP Medication
8 Participants
4 Participants
4 Participants
Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3
Increase concomitant ITP medication from Baseline
1 Participants
0 Participants
0 Participants
Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3
Platelet transfusion
0 Participants
0 Participants
0 Participants
Number of Participants Who Required a Protocol-defined Rescue Treatment During Part 2/3
Splenectomy
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline, Week 6, Week 12, and Week 24 of Part 1

Population: ITT 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 ITT Population.

The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment, after 12 weeks of treatment and at the end of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 - Q26 (excluding any answer that is 'Not applicable'). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=5 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1
Baseline, n=5, 5, 5
73.18 Score on scale
Standard Deviation 15.743
53.95 Score on scale
Standard Deviation 16.534
74.80 Score on scale
Standard Deviation 17.199
Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1
Week 6, n=4, 5, 5
82.84 Score on scale
Standard Deviation 9.131
61.57 Score on scale
Standard Deviation 13.664
71.54 Score on scale
Standard Deviation 14.798
Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1
Week 12, n=4, 4, 4
84.14 Score on scale
Standard Deviation 11.712
66.43 Score on scale
Standard Deviation 12.349
65.58 Score on scale
Standard Deviation 17.887
Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline, Week 6, Week 12, and Week 24 as Assessed Using the KIT Questionnaire During the Dose Finding Period, Part 1
Week 24, n= 3, 4, 3
76.38 Score on scale
Standard Deviation 20.228
82.50 Score on scale
Standard Deviation 15.995
78.87 Score on scale
Standard Deviation 12.056

SECONDARY outcome

Timeframe: Baseline and Week 6 of Part 2

Population: ITT 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 ITT Population.

The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 - Q26 (excluding any answer that is 'Not applicable'). The code list used for the individual question scores is: 1 = never, 2 = seldom, 3 = sometimes, 4 = often, 5 = always and 9 = not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=8 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=16 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=9 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
n=19 Participants
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
n=5 Participants
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
n=10 Participants
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2
Baseline, n=6, 11, 9, 10, 2, 8
83.94 Score on scale
Standard Deviation 8.674
76.84 Score on scale
Standard Deviation 15.049
71.05 Score on scale
Standard Deviation 19.581
66.36 Score on scale
Standard Deviation 17.321
82.61 Score on scale
Standard Deviation 7.686
78.23 Score on scale
Standard Deviation 9.575
Kids' ITP Tool (KIT) Questionnaire Total Score at Baseline and Week 6as Assessed Using the KIT Questionnaire During the Randomized Period, Part 2
Week 6, n= 8,11,7,13, 5, 9
79.46 Score on scale
Standard Deviation 10.971
79.46 Score on scale
Standard Deviation 13.899
74.65 Score on scale
Standard Deviation 20.968
80.16 Score on scale
Standard Deviation 13.776
88.01 Score on scale
Standard Deviation 3.333
80.85 Score on scale
Standard Deviation 15.082

SECONDARY outcome

Timeframe: From Baseline to end of treatment up to Study Week 31

Population: ITT 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 ITT Population.

The KIT questionnaire measures the impact on the quality of life determined by the participant and the guardian by self reported outcomes at Baseline or the Screening Visit, after 6 weeks of treatment, after 12 weeks of treatment and at the end of treatment or withdrawal from the study. The KIT total score is calculated from the scores of each of the individual questions from Q1 - Q26 (excluding any answer that is 'Not applicable'). The code list used for the individual question scores is: 1=never, 2=seldom, 3=sometimes, 4=often, 5=always and 9=not applicable. The range of values the total score can take is 0 (worst) to 100 (best). For subjects under the age of six, the family questionnaire (parental proxy) has been used.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=24 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=28 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=15 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3
Baseline, n=17, 18, 10
79.34 Score on scale
Standard Deviation 13.315
70.59 Score on scale
Standard Deviation 16.237
79.10 Score on scale
Standard Deviation 9.016
Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3
Week 6, n=11, 13, 9
79.46 Score on scale
Standard Deviation 13.899
80.16 Score on scale
Standard Deviation 13.776
80.85 Score on scale
Standard Deviation 15.082
Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3
Week 12, n=9, 7, 2
84.25 Score on scale
Standard Deviation 7.531
76.48 Score on scale
Standard Deviation 19.948
88.10 Score on scale
Standard Deviation 11.166
Kids' ITP Tools (KIT) Questionnaire Total Score at Baseline, Week, 6, Week 12, and End of Treatment Visit as Assessed Using the KIT Questionnaire During the Eltrombopag Open-Label Period, Part 2/3
Week 24, n=17, 11, 8
82.16 Score on scale
Standard Deviation 16.926
83.93 Score on scale
Standard Deviation 13.327
77.93 Score on scale
Standard Deviation 22.971

SECONDARY outcome

Timeframe: From Baseline through Week 7 of Part 2

Population: ITT 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 ITT Population.

The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=8 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=16 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=9 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
n=19 Participants
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
n=5 Participants
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
n=10 Participants
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 7, Grades 1-4, n=8, 16, 9, 17, 5, 9
7 Participants
5 Participants
7 Participants
5 Participants
4 Participants
4 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 7, Grades 0-1, n=8, 16, 9, 17, 5, 9
4 Participants
15 Participants
8 Participants
16 Participants
3 Participants
7 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Baseline, Grades 1-4, n=8, 16, 9, 19, 5, 10
6 Participants
16 Participants
7 Participants
11 Participants
5 Participants
8 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Baseline, Grades 0-1, n=8, 16, 9, 19, 5, 10
6 Participants
13 Participants
6 Participants
17 Participants
4 Participants
6 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Baseline, Grades 2-4, n=8, 16, 9, 19, 5, 10
2 Participants
3 Participants
3 Participants
2 Participants
1 Participants
4 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 1, Grades 1-4, n=8, 16, 9, 17, 5, 10
7 Participants
9 Participants
6 Participants
7 Participants
3 Participants
7 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 1, Grades 0-1, n=8, 16, 9, 17, 5, 10
3 Participants
14 Participants
6 Participants
17 Participants
5 Participants
5 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 1, Grades 2-4, n=8, 16, 9, 17, 5, 10
5 Participants
2 Participants
3 Participants
0 Participants
0 Participants
5 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 2, Grades 1-4, n=8, 16, 9, 17, 5, 10
7 Participants
11 Participants
6 Participants
6 Participants
2 Participants
5 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 2, Grades 0-1, n=8, 16, 9, 17, 5, 10
5 Participants
13 Participants
7 Participants
16 Participants
3 Participants
7 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 2, Grades 2-4, n=8, 16, 9, 17, 5, 10
3 Participants
3 Participants
2 Participants
1 Participants
2 Participants
3 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 3, Grades 1-4, n=8, 16, 9, 16, 5, 9
6 Participants
10 Participants
7 Participants
6 Participants
2 Participants
5 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 3, Grades 0-1, n=8, 16, 9, 16, 5, 9
5 Participants
14 Participants
7 Participants
14 Participants
3 Participants
7 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 3, Grades 2-4, n=8, 16, 9, 16, 5, 9
3 Participants
2 Participants
2 Participants
2 Participants
2 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 4, Grades 1-4, n=8, 16, 9, 17, 5, 9
6 Participants
7 Participants
7 Participants
7 Participants
2 Participants
6 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 4, Grades 0-1, n=8, 16, 9, 17, 5, 9
6 Participants
16 Participants
8 Participants
17 Participants
3 Participants
7 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 4, Grades 2-4, n=8, 16, 9, 17, 5, 9
2 Participants
0 Participants
1 Participants
0 Participants
2 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 5, Grades 1-4, n=8, 16, 9, 16, 5, 9
6 Participants
8 Participants
7 Participants
3 Participants
4 Participants
5 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 5, Grades 0-1, n=8, 16, 9, 16, 5, 9
4 Participants
14 Participants
8 Participants
16 Participants
4 Participants
8 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 5, Grades 2-4, n=8, 16, 9, 16, 5, 9
4 Participants
2 Participants
1 Participants
0 Participants
1 Participants
1 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 6, Grades 1-4, n=8, 16, 9, 17, 5, 9
5 Participants
2 Participants
7 Participants
4 Participants
4 Participants
4 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 6, Grades 0-1, n=8, 16, 9, 17, 5, 9
7 Participants
16 Participants
7 Participants
16 Participants
4 Participants
9 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 6, Grades 2-4, n=8, 16, 9, 17, 5, 9
1 Participants
0 Participants
2 Participants
1 Participants
1 Participants
0 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2
Week 7, Grades 2-4, n=8, 16, 9, 17, 5, 9
4 Participants
1 Participants
1 Participants
1 Participants
2 Participants
2 Participants

SECONDARY outcome

Timeframe: From Baseline of Part 2/3 through Follow-up

Population: ITT 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 ITT Population.

The WHO Bleeding Scale is a measure of bleeding severity with the following grades: Grade 0 = no bleeding, Grade 1 = petechiae, Grade 2 = mild blood loss, Grade 3 = gross bleeding and Grade 4 = debilitating blood loss. The WHO grades were dichotomized into the following categories: no bleeding=Grade 0; any bleeding=Grades 1 to 4; no clinically significant bleeding=Grades 0 to 1; clinically significant bleeding=Grades 2 to 4. For participants randomized to Placebo in Part 2, Baseline defined as Week 7 of Part 2. For participants randomized to Eltrombopag in Part 2, Baseline defined as Day 1 of Part 2.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=24 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=28 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=15 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 5, Grades 1-4, n=24, 24, 13
11 Participants
4 Participants
9 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 5, Grades 0-1, n=24, 24, 13
21 Participants
24 Participants
12 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 5, Grades 2-4, n=24, 24, 13
3 Participants
0 Participants
1 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 6, Grades 1-4, n=23, 24, 12
6 Participants
6 Participants
4 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Baseline, Grades 1-4, n=24, 28, 15
23 Participants
18 Participants
12 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Baseline, Grades 0-1, n=24, 28, 15
17 Participants
25 Participants
9 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Baseline, Grades 2-4, n=24, 28, 15
7 Participants
3 Participants
6 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 1, Grades 1-4, n=24, 26, 15
14 Participants
13 Participants
9 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 1, Grades 0-1, n=24, 26, 15
20 Participants
24 Participants
9 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 1, Grades 2-4, n=24, 26, 15
4 Participants
2 Participants
6 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 2, Grades 1-4, n=24, 26, 14
15 Participants
12 Participants
8 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 2, Grades 0-1, n=24, 26, 14
21 Participants
23 Participants
10 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 2, Grades 2-4, n=24, 26, 14
3 Participants
3 Participants
4 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 3, Grades 1-4, n=24, 25, 14
13 Participants
9 Participants
6 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 3, Grades 0-1, n=24, 25, 14
21 Participants
23 Participants
12 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 3, Grades 2-4, n=24, 25, 14
3 Participants
2 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 4, Grades 1-4, n=24, 26, 13
10 Participants
11 Participants
8 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 4, Grades 0-1, n=24, 26, 13
24 Participants
26 Participants
10 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 4, Grades 2-4, n=24, 26, 13
0 Participants
0 Participants
3 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 6, Grades 0-1, n=23, 24, 12
23 Participants
22 Participants
12 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 6, Grades 2-4, n=23, 24, 12
0 Participants
2 Participants
0 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 7, Grades 1-4, n=22, 25, 14
8 Participants
7 Participants
4 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 7, Grades 0-1, n=22, 25, 14
20 Participants
24 Participants
12 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 7, Grades 2-4, n=22, 25, 14
2 Participants
1 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 8, Grades 1-4, n=19, 21, 11
10 Participants
6 Participants
5 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 8, Grades 0-1, n=19, 21, 11
19 Participants
19 Participants
9 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 8, Grades 2-4, n=19, 21, 11
0 Participants
2 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 9, Grades 1-4, n=17, 16, 12
8 Participants
5 Participants
6 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 9, Grades 0-1, n=17, 16, 12
13 Participants
16 Participants
10 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 9, Grades 2-4, n=17, 16, 12
4 Participants
0 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 10, Grades 1-4, n=16, 14, 11
5 Participants
5 Participants
7 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 10, Grades 0-1, n=16, 14, 11
16 Participants
12 Participants
11 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 10, Grades 2-4, n=16, 14, 11
0 Participants
2 Participants
0 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 11, Grades 1-4, n=16, 15, 12
15 Participants
5 Participants
7 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 11, Grades 0-1, n=16, 15, 12
16 Participants
13 Participants
10 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 11, Grades 2-4, n=16, 15, 12
0 Participants
2 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 12, Grades 1-4, n=19, 16, 9
6 Participants
7 Participants
4 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 12, Grades 0-1, n=19, 16, 9
18 Participants
14 Participants
7 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 12, Grades 2-4, n=19, 16, 9
1 Participants
2 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 13, Grades 1-4, n=12, 14, 10
6 Participants
5 Participants
6 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 13, Grades 0-1, n=12, 14, 10
12 Participants
13 Participants
10 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 13, Grades 2-4, n=12, 14, 10
0 Participants
1 Participants
0 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 14, Grades 1-4, n=15, 11, 17
3 Participants
2 Participants
3 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 14, Grades 0-1, n=15, 11, 17
15 Participants
11 Participants
5 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 14, Grades 2-4, n=15, 11, 17
0 Participants
0 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 15, Grades 1-4, n=12, 14, 6
6 Participants
3 Participants
3 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 15, Grades 0-1, n=12, 14, 6
10 Participants
14 Participants
5 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 15, Grades 2-4, n=12, 14, 6
2 Participants
0 Participants
1 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 16, Grades 1-4, n=17, 15, 9
7 Participants
8 Participants
4 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 16, Grades 0-1, n=17, 15, 9
17 Participants
14 Participants
9 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 16, Grades 2-4, n=17, 15, 9
0 Participants
1 Participants
0 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 17, Grades 1-4, n=13, 11, 5
5 Participants
3 Participants
4 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 17, Grades 0-1, n=13, 11, 5
13 Participants
11 Participants
5 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 17, Grades 2-4, n=13, 11, 5
0 Participants
0 Participants
0 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 18, Grades 1-4, n=16, 12 ,4
3 Participants
2 Participants
3 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 18, Grades 0-1, n=16, 12 ,4
16 Participants
11 Participants
4 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 18, Grades 2-4, n=16, 12 ,4
0 Participants
1 Participants
0 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 19, Grades 1-4, n=14, 15, 7
3 Participants
4 Participants
1 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 19, Grades 0-1, n=14, 15, 7
14 Participants
14 Participants
7 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 19, Grades 2-4, n=14, 15, 7
0 Participants
1 Participants
0 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 20, Grades 1-4, n=13, 13, 8
2 Participants
3 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 20, Grades 0-1, n=13, 13, 8
13 Participants
13 Participants
6 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 20, Grades 2-4, n=13, 13, 8
0 Participants
0 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 21, Grades 1-4, n=4, 10, 3
1 Participants
0 Participants
0 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 21, Grades 0-1, n=4, 10, 3
4 Participants
10 Participants
3 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 21, Grades 2-4, n=4, 10, 3
0 Participants
0 Participants
0 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 22, Grades 1-4, n=12,7, 5
2 Participants
2 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 22 Grades 0-1, n=12,7, 5
12 Participants
6 Participants
5 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 22 Grades 2-4, n=12,7, 5
0 Participants
1 Participants
0 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 23, Grades 1-4, n=8, 7,6
1 Participants
1 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 23, Grades 0-1, n=8, 7,6
8 Participants
7 Participants
6 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 23, Grades 2-4, n=8, 7,6
0 Participants
0 Participants
0 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 24, Grades 1-4, n=23, 24, 13
5 Participants
5 Participants
4 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 24, Grades 0-1, n=23, 14, 13
21 Participants
24 Participants
12 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Week 24, Grades 2-4, n=23, 14, 13
2 Participants
0 Participants
1 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Follow Up Week 1, Grades 1-4, n=8, 5, 3
5 Participants
1 Participants
3 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Follow Up Week 1, Grades 0-1, n=8, 5, 3
8 Participants
4 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Follow Up Week 1, Grades 2-4, n=8, 5, 3
0 Participants
1 Participants
1 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Follow Up Week 2, Grades 1-4, n=7, 7, 7
2 Participants
6 Participants
2 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Follow Up Week 2, Grades 0-1, n=7, 7, 7
7 Participants
6 Participants
6 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Follow Up Week 2, Grades 2-4, n=7, 7, 7
0 Participants
1 Participants
1 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Follow Up Week 3, Grades 1-4, n=5, 5, 5
1 Participants
2 Participants
4 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Follow Up Week 3, Grades 0-1, n=5, 5, 5
5 Participants
5 Participants
4 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Follow Up Week 3, Grades 2-4, n=5, 5, 5
0 Participants
0 Participants
1 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Follow Up Week 4, Grades 1-4, n=9, 14, 8
5 Participants
4 Participants
3 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Follow Up Week 4, Grades 0-1, n=9, 14, 8
8 Participants
13 Participants
7 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Follow Up Week 4, Grades 2-4, n=9, 14, 8
1 Participants
1 Participants
1 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Any Follow Up Visit, Grades 1, n=15, 18, 10
7 Participants
10 Participants
5 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Any Follow Up Visit, Grades 0-1, n=15, 18, 10
15 Participants
18 Participants
9 Participants
Number of Participants With Any Bleeding, no Clinically Significant Bleeding and Significant Bleeding as Assessed Using the World Health Organization (WHO) Bleeding Scale During Part 2/3
Any Follow Up Visit, Grades 2-4, n=15, 18, 10
1 Participants
3 Participants
3 Participants

SECONDARY outcome

Timeframe: Post-Baseline from Week 1 through Follow-up up to Study Week 35

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.

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

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=15 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=21 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=44 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
n=65 Participants
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
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
Potassium, high, n=15, 21, 44, 65
7 Participants
0 Participants
3 Participants
9 Participants
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
Potassium, low, n=15, 21, 44, 65,
3 Participants
4 Participants
8 Participants
14 Participants
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
Sodium, high, n=15, 21, 44, 65
2 Participants
1 Participants
2 Participants
6 Participants
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
Sodium, low, n=15, 21, 44, 65
2 Participants
1 Participants
4 Participants
9 Participants
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
AST high, n=15, 21, 44, 65
5 Participants
4 Participants
7 Participants
17 Participants
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
AST low, n=15, 21, 44, 65
1 Participants
1 Participants
3 Participants
7 Participants
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
ALT, high, n= 15, 21, 44, 65
2 Participants
3 Participants
3 Participants
14 Participants
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
ALT, low, n= 15, 21, 44, 65
2 Participants
3 Participants
4 Participants
11 Participants
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
Total Bilirubin, high, n=15, 21, 44, 65
5 Participants
2 Participants
2 Participants
9 Participants
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
Total Bilirubin, low, n=15, 21, 44, 65
6 Participants
0 Participants
16 Participants
31 Participants
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
Direct Bilirubin, high, n=10, 16, 34, 55
0 Participants
1 Participants
1 Participants
3 Participants
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
Direct Bilirubin, low, n=10, 16, 34, 55
1 Participants
0 Participants
6 Participants
8 Participants
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
Albumin, high, n=15, 21, 24, 65
3 Participants
3 Participants
2 Participants
9 Participants
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
Albumin, low, n=15, 21, 24, 65
1 Participants
3 Participants
5 Participants
11 Participants
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
ALP, high, n=15, 21, 24, 65
4 Participants
1 Participants
6 Participants
13 Participants
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
ALP, low, n=15, 21, 24, 65
2 Participants
2 Participants
4 Participants
11 Participants
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
PT INR, high, n=15, 20, 42, 64
2 Participants
1 Participants
4 Participants
12 Participants
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
PT INR, low, n=15, 20, 42, 64
0 Participants
0 Participants
0 Participants
1 Participants
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
PT, high, n=13, 20, 36, 61
5 Participants
5 Participants
8 Participants
24 Participants
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
PT, low, n=13, 20, 36, 61
0 Participants
1 Participants
0 Participants
3 Participants
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
PTT, high, n=15, 21, 41, 63
4 Participants
2 Participants
1 Participants
11 Participants
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
PTT, low, n=15, 21, 41, 63
0 Participants
1 Participants
1 Participants
9 Participants
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
Glucose, high, n=15, 21, 44, 65
5 Participants
5 Participants
7 Participants
27 Participants
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
Glucose, low, n=15, 21, 44, 65
7 Participants
6 Participants
16 Participants
29 Participants

SECONDARY outcome

Timeframe: Post-Baseline from Week 1 through Follow-up up to Study Week 35

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.

Hematology parameters included: erythrocytes (RR: 4.2 - 6.1 teragrams per liter \[TI/L\]), hemoglobin (RR: 125 - 165 g/L), hematocrit (RR: 0.36 - 0.46), platelets (RR: 170 - 430 gigagrams per liter \[GI/L\]), mean platelet volume (MPV, RR: 4 - 14 femotoliter \[fL\]), leukocytes (RR: 3.4 - 11.2 GI/L), total neutrophils (RR: 2.1 - 4.9 GI/L), lymphocytes (RR: 1.4 - 2.9 GI/L), monocytes (RR: 0.2 - 0.9 GI/L), eosinophils (RR: 0.2 - 0.7 GI/L), and basophils (RR: 0.02 - 0.12 GI/L). Baseline values were obtained at Day 1. The number of participants with the indicated hematology parameters 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

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=15 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=21 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=44 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
n=65 Participants
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Mean Platelet Volume, high, n=12, 17, 40, 59
10 Participants
10 Participants
23 Participants
47 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Erythrocytes high, n=15, 21, 44, 65
5 Participants
0 Participants
7 Participants
15 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Erythrocytes low, n=15, 21, 44, 65
2 Participants
8 Participants
13 Participants
24 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Hemoglobin, high, n= 15, 21, 44, 65
2 Participants
2 Participants
2 Participants
8 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Hemoglobin low, n= 15, 21, 44, 65
10 Participants
5 Participants
15 Participants
32 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Hematocrit, high, n=15, 21, 44, 65
1 Participants
0 Participants
0 Participants
5 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Hematocrit, low, n=15, 21, 44, 65
10 Participants
11 Participants
22 Participants
39 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Platelets, high, n=15, 21, 44, 65
9 Participants
0 Participants
6 Participants
14 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Platelets, low, n=15, 21, 44, 65
15 Participants
21 Participants
44 Participants
65 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Leukocytes, high, n=15, 21, 44, 65
6 Participants
5 Participants
8 Participants
27 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Leukocytes, low, n=15, 21, 44, 65
4 Participants
5 Participants
10 Participants
19 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Neutrophils, high, n=15, 21, 44, 65
7 Participants
5 Participants
11 Participants
33 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Neutrophils, low, n=15, 21, 44, 65
3 Participants
4 Participants
10 Participants
21 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Lymphocytes, high, n=15, 21, 44, 65
1 Participants
3 Participants
5 Participants
11 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Lymphocytes, low, n=15, 21, 44, 65
5 Participants
6 Participants
10 Participants
25 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Monocytes, high, n=15, 21, 44, 65
3 Participants
3 Participants
7 Participants
15 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Monocytes, low, n=15, 21, 44, 65
4 Participants
7 Participants
10 Participants
23 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Eosinophils, high, n=15, 21, 44, 65
5 Participants
3 Participants
11 Participants
24 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Eosinophils, low, n=15, 21, 44, 65
4 Participants
2 Participants
5 Participants
9 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Basophils, high, n=15, 21, 44, 65
6 Participants
5 Participants
10 Participants
20 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Basophils, low, n=15, 21, 44, 65
2 Participants
0 Participants
1 Participants
1 Participants
Number of Participants With the Indicated Hematology Parameters Falling Outside of the Reference Range at Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Mean Platelet Volume, low, n=12, 17, 40, 59
4 Participants
6 Participants
10 Participants
16 Participants

SECONDARY outcome

Timeframe: Post-Baseline from Week 1 through Follow-up up to Study Week 35

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.

Renal parameters included: creatinine (RR: 44.2 - 88.4 umol/L), creatinine clearance derived (RR: 89.0 - 165.0 milliliter per minute \[ ml/min\]), protein/creatinine (RR: 0.113- 18.0992 microgram per millimoles \[mg/mmol\]), and urea (RR: 1.785- 8.925 mmol/L). Baseline values were obtained at Day 1. The number of participants with the indicated renal parameters data outside 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

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=15 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=21 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=44 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
n=65 Participants
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Creatinine, high, n=15, 21, 44, 65
1 Participants
3 Participants
6 Participants
13 Participants
Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Creatinine, low, n=15, 21, 44, 65
5 Participants
4 Participants
4 Participants
12 Participants
Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Creatinine Clearance Derived, high, n=15, 21,44,65
11 Participants
17 Participants
28 Participants
46 Participants
Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Creatinine Clearance Derived, low, n=15, 21,44,65
0 Participants
2 Participants
3 Participants
4 Participants
Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Protein/Creatinine, high, n=12, 19, 38, 58
1 Participants
2 Participants
4 Participants
18 Participants
Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Protein/Creatinine, low, n=12, 19, 38, 58
1 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Urea, high, n=15, 21, 44, 65
1 Participants
2 Participants
2 Participants
5 Participants
Number of Participants With the Indicated Renal Parameters Falling Outside of the Reference Range Any Time Post-Baseline During Part 1, Part 2, and Part 2/3
Urea, low, n=15, 21, 44, 65
5 Participants
1 Participants
9 Participants
11 Participants

SECONDARY outcome

Timeframe: From Baseline up to Study Week 24 of Part 1

Population: Safety Population, only those participants enrolled during Part 1 were analyzed.

Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with a positive result at any time post Baseline were reported. A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=5 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1
WBC Casts
0 Participants
0 Participants
0 Participants
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1
Epithelial Renal Cell Casts
0 Participants
0 Participants
2 Participants
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 1
RBC Casts
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: From Baseline and post-Baseline up to Study Week 7 of Part 2

Population: Safety Population, only those participants enrolled during Part 2 were analyzed.

Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The nmber of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=8 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=16 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=9 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
n=17 Participants
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
n=4 Participants
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
n=11 Participants
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2
Pre-trt Epithelial Renal Tubular Cell Casts
0 Participants
2 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2
Pre-trt RBC Casts
0 Participants
1 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2
Pre-trt WBC Casts
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2
Post-BL Epithelial Renal Tubular Cell Casts
1 Participants
3 Participants
0 Participants
0 Participants
1 Participants
0 Participants
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2
Post-BL RBC Casts
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2
Post-BL WBC Casts
0 Participants
0 Participants
0 Participants
0 Participants
0 Participants
1 Participants

SECONDARY outcome

Timeframe: From Baseline and post-Baseline up to Study Week 31 of Part 2/3

Population: Safety Population, only those participants enrolled during Part 2/3 were analyzed.

Urine microscopy included Red Blood Cell (RBC) casts, white blood cell (WBC) casts, and epithelial renal tubular cell casts. Urine microscopy data was reviewed by the Medical Monitor in order to classify the results as positive or negative. The number of participants with positive finding at Baseline and at anytime post-Baseline (Post-BL) were reported. Baseline was defined as the value obtained at the first visit before treatment (Pre-trt). A positive result indicated if the result was positive for at least one of RBC casts, WBC casts, or epithelial renal tubular cell casts. 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.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=24 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=26 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=15 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3
Pre-trt Epithelial Renal Tubular Cell Casts
3 Participants
0 Participants
1 Participants
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3
Pre-trt RBC Casts
1 Participants
0 Participants
0 Participants
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3
Pre-trt WBC Casts
0 Participants
0 Participants
0 Participants
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3
Post-BL Epithelial Renal Tubular Cell Casts
3 Participants
2 Participants
1 Participants
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3
Post-BL RBC Casts
0 Participants
0 Participants
1 Participants
Number of Participants With a Positive Urine Microscopy Parameters Any Time Post-Baseline During Part 2/3
Post-BL WBC Casts
1 Participants
0 Participants
1 Participants

SECONDARY outcome

Timeframe: From Baseline through Study Week 35

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.

Vital sign assessments included systolic blood pressure (SBP) and diastolic blood pressure (DBP) measurements that were measured before any blood draw at the following scheduled time points: Screening, Day 1, each week from Week 1 to Week 24, at each Follow-up week (Week 1-4) and the maximum post- Baseline (BL) visit. BL is defined as the value obtained on Day 1of treatment. The maximum post-BL visit (MPB) included any scheduled and unscheduled post-BL assessment. Reference ranges (RR) for SBP (mmHg) (Lower limit of normal, normal, Upper limit of normal) for Cohort 1: \<85, 85-115, \>115; for Cohort 2: \<85, 85-120,\>120; and Cohort 3: \<95, 95-135, \>135. RR for DBP (mmHg) for Cohort 1: \<45, 45-70,\>70; for Cohort 2: \<50, 50-75, \>75; and Cohort 3: \<55, 55-85, \>85.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=15 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=21 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=44 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
n=65 Participants
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Screening, DBP, high, n=15 ,20 ,41 ,40
1 Participants
4 Participants
3 Participants
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Screening, DBP, low, n=15, 20, 41, 40
0 Participants
2 Participants
6 Participants
5 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Day 1, DBP, high, n=14, 18, 38, 59
2 Participants
4 Participants
3 Participants
7 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Day 1, DBP, low, n=14, 18, 38, 59
1 Participants
1 Participants
3 Participants
4 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 1, DBP, high, n=14, 19, 42, 63
1 Participants
3 Participants
4 Participants
5 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 1, DBP, low, n=14, 19, 42, 63
1 Participants
1 Participants
4 Participants
5 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 2, DBP, high, n=15, 20, 42, 61
3 Participants
2 Participants
2 Participants
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 2, DBP, low, n=15, 20, 42, 61
2 Participants
3 Participants
4 Participants
5 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 3, DBP, high,n=15, 21, 41, 60
1 Participants
3 Participants
3 Participants
6 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 3, DBP, low,n=15, 21, 41, 60
2 Participants
3 Participants
5 Participants
5 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 4, DBP,high, n=15, 21, 42, 62
0 Participants
3 Participants
3 Participants
6 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 4, DBP,low, n=15, 21, 42, 62
4 Participants
4 Participants
3 Participants
5 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 5, DBP, high, n=15, 19, 40, 59
1 Participants
2 Participants
4 Participants
8 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 5, DBP, low, n=15, 19, 40, 59
1 Participants
1 Participants
5 Participants
5 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 6, DBP, high, n=14, 21, 42, 58
1 Participants
2 Participants
3 Participants
5 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 6, DBP, low, n=14, 21, 42, 58
0 Participants
0 Participants
3 Participants
4 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 7, DBP, high, n=15, 21, 42, 58
1 Participants
4 Participants
6 Participants
7 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 7, DBP, low, n=15, 21, 42, 58
0 Participants
1 Participants
2 Participants
4 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 8, DBP,high,n=15, 0, 0, 49
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
4 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 8, DBP,low,n=15, 0, 0, 49
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
6 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 9, DBP, high, n=15, 0, 0, 45
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
4 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 9, DBP, low, n=15, 0, 0, 45
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
6 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 10, DBP, high, n=15, 0, 0, 40
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
6 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 10, DBP, low, n=15, 0, 0, 40
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 11, DBP, high, n=13, 0, 0, 41
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
4 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 11, DBP, low, n=13, 0, 0, 41
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 12, DBP, high, n=13, 0, 0, 42
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
5 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 12, DBP, low, n=13, 0, 0, 42
3 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 13, DBP, high, n=12, 0, 0, 32
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
0 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 13, DBP, low, n=12, 0, 0, 32
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
5 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 14, DBP, high, n=9, 0, 0, 32
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 14, DBP, low, n=9, 0, 0, 32
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 15, DBP, high, n=11, 0, 0, 31
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 15, DBP, low, n=11, 0, 0, 31
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
0 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 16, DBP,high,n=12, 0, 0, 39
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
2 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 16, DBP,low,n=12, 0, 0, 39
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 17, DBP,high,n=5, 0, 0, 29
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
2 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 17, DBP,low,n=5, 0, 0, 29
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 18, DBP,high,n=9, 0, 0, 32
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 18, DBP,low,n=9, 0, 0, 32
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 19, DBP,high,n=5, 0, 0, 34
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 19, DBP,low,n=5, 0, 0, 34
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
2 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 20, DBP,high,n=13, 0, 0, 33
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
0 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 20, DBP,low,n=13, 0, 0, 33
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 21, DBP,high,n=10, 0, 0, 17
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 21, DBP,low,n=10, 0, 0, 17
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 22, DBP,high,n=11, 0, 0, 23
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 22, DBP,low,n=11, 0, 0, 23
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
0 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 23, DBP,high,n=11, 0, 0, 21
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 23, DBP,low,n=11, 0, 0, 21
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
2 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 24 DBP,high,n=15, 0, 0, 58
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
5 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 24, DBP,low,n=15, 0, 0, 58
3 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 1, DBP,high,n=5, 0, 0, 13
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
2 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 1, DBP,low,n=5, 0, 0, 13
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 2, DBP,high,n=5, 0, 0, 21
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
2 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 2, DBP,low,n=5, 0, 0, 21
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 3, DBP,high,n=5, 0, 0, 14
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
2 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 3, DBP,low,n=5, 0, 0, 14
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
0 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 4, DBP,high,n=3, 0, 0, 31
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
7 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 4, DBP,low,n=3, 0, 0, 31
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
5 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Screening, SBP, high, n=15, 20, 41, 40
4 Participants
4 Participants
10 Participants
10 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Screening, SBP, low, n=15, 20, 41, 40
3 Participants
0 Participants
3 Participants
2 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Day 1, SBP,high,n=14, 18, 38, 59
4 Participants
5 Participants
9 Participants
14 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Day 1, SBP,low,n=14, 18, 38, 59
0 Participants
1 Participants
4 Participants
4 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 1, SBP,high,n=14, 19, 42, 63
3 Participants
6 Participants
14 Participants
18 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 1, SBP,low,n=14, 19, 42, 63
2 Participants
0 Participants
4 Participants
8 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 2, SBP,high,n=15, 20, 43, 62
4 Participants
7 Participants
7 Participants
15 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 2, SBP,low,n=15, 20, 43, 62
1 Participants
2 Participants
5 Participants
6 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 3, SBP,high,n=15, 21, 41, 60
3 Participants
4 Participants
12 Participants
17 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 3, SBP,low,n=15, 21, 41, 60
1 Participants
2 Participants
2 Participants
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 4, SBP,high,n=15, 21, 42, 62
4 Participants
6 Participants
10 Participants
16 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 4, SBP,low,n=15, 21, 42, 62
4 Participants
1 Participants
3 Participants
2 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 5, SBP,high,n=15, 19, 40, 59
5 Participants
5 Participants
13 Participants
17 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 5, SBP, low, n=15, 19, 40, 59
2 Participants
1 Participants
3 Participants
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 6, SBP,high,n=14, 21, 42, 58
4 Participants
8 Participants
11 Participants
16 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 6, SBP,low,n=14, 21, 42, 58
2 Participants
1 Participants
3 Participants
5 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 7, SBP,high,n=15, 21, 42, 58
5 Participants
5 Participants
9 Participants
13 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 7, SBP,low,n=15, 21, 42, 58
1 Participants
0 Participants
2 Participants
5 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 8, SBP,high,n=15, 0, 0, 49
3 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
16 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 8, SBP,low,n=15, 0, 0, 49
4 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
4 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 9, SBP,high,n=15, 0, 0, 45
4 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
15 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 9, SBP,low,n=15, 0, 0, 45
3 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
2 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 10, SBP,high,n=15, 0, 0, 40
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
10 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 10, SBP,low,n=15, 0, 0, 40
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 11, SBP,high,n=13, 0, 0, 41
4 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
9 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 11, SBP,low,n=13, 0, 0, 41
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
2 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 12, SBP,high,n=13, 0, 0, 42
3 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
10 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 12, SBP,low,n=13, 0, 0, 42
3 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 13, SBP,high,n=12, 0, 0, 32
3 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
8 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 13, SBP,low,n=12, 0, 0, 32
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 14, SBP,high,n=9, 0, 0, 32
4 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
10 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 14, SBP,low,n=9, 0, 0, 32
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 15, SBP,high,n=11, 0, 0, 31
3 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
9 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 15, SBP,low,n=11, 0, 0, 31
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 16 SBP,high,n=12, 0, 0, 39
5 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
14 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 16, SBP,low,n=12, 0, 0, 39
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 17, SBP,high,n=5, 0, 0, 29
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
9 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 17, SBP,low,n=5, 0, 0, 29
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
0 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 18, SBP,high,n=9, 0, 0, 32
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
10 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 18, SBP,low,n=9, 0, 0, 32
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 19, SBP,high,n=5, 0, 0, 34
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
9 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 19, SBP,low,n=5, 0, 0, 34
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
2 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 20, SBP,high,n=13, 0, 0, 33
6 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
10 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 20, SBP,low,n=13, 0, 0, 33
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 21, SBP,high,n=10, 0, 0, 17
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
0 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 21, SBP,low,n=10, 0, 0, 17
3 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
0 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 22, SBP,high,n=11, 0, 0, 23
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
8 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 22, SBP,low,n=11, 0, 0, 23
3 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
0 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 23, SBP,high,n=11, 0, 0, 21
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
6 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 23, SBP,low,n=11, 0, 0, 21
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
1 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 24, SBP,high,n=15, 0, 0, 58
4 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
19 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
Week 24, SBP, low, n=15, 0, 0, 58
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
2 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 1, SBP, high,n=5, 0, 0, 13
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
4 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 1, SBP, low,n=5, 0, 0, 13
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
0 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 2, SBP, high,n=5, 0, 0, 21
2 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 2, SBP, low,n=5, 0, 0, 21
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 3, SBP, high,n=5, 0, 0, 14
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
4 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 3, SBP, low,n=5, 0, 0, 14
0 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
0 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 4, SBP, high,n=3, 0, 0, 31
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
10 Participants
Number of Participants With the Indicated Vital Signs Falling Outside of the Reference Range During Part 1, Part 2, and Part 2/3
FU Week 4, SBP,low,n=3, 0, 0, 31
1 Participants
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
NA Participants
Part 2 ended at Week 7 so no participants were analyzed for this parameter at this time point.
3 Participants

SECONDARY outcome

Timeframe: From Baseline through Week 24

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 .

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 value included any scheduled and unscheduled post-Baseline assessment.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=5 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
FU Week 1, n=1,1,3
20.0 Breaths per min
Standard Deviation NA
There were too few participants available to collect data at this time point to calculate a standard deviation.
20.0 Breaths per min
Standard Deviation NA
There were too few participants available to collect data at this time point to calculate a standard deviation.
22.0 Breaths per min
Standard Deviation 2.00
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
BL, n=4, 5, 4
20.0 Breaths per min
Standard Deviation 0.00
21.4 Breaths per min
Standard Deviation 4.10
25.5 Breaths per min
Standard Deviation 4.43
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 1, n=4,5,4
21.5 Breaths per min
Standard Deviation 4.43
22.0 Breaths per min
Standard Deviation 6.00
26.5 Breaths per min
Standard Deviation 6.40
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 2, n=5,5,4
20.6 Breaths per min
Standard Deviation 3.44
19.4 Breaths per min
Standard Deviation 4.98
24.0 Breaths per min
Standard Deviation 5.42
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 3, n=5,5,5
22.0 Breaths per min
Standard Deviation 5.66
17.0 Breaths per min
Standard Deviation 5.10
23.6 Breaths per min
Standard Deviation 6.07
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 4, n=5,5,5
18.8 Breaths per min
Standard Deviation 1.79
17.2 Breaths per min
Standard Deviation 4.82
25.4 Breaths per min
Standard Deviation 5.98
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 5, n=5,5,4
20.4 Breaths per min
Standard Deviation 2.19
20.2 Breaths per min
Standard Deviation 6.87
24.3 Breaths per min
Standard Deviation 5.56
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 6, n=5,5,4
18.4 Breaths per min
Standard Deviation 2.61
20.2 Breaths per min
Standard Deviation 5.02
24.5 Breaths per min
Standard Deviation 2.52
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 7, n=5,5,5
19.2 Breaths per min
Standard Deviation 1.10
23.4 Breaths per min
Standard Deviation 9.15
24.4 Breaths per min
Standard Deviation 6.69
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 8, n=5,5,5
19.8 Breaths per min
Standard Deviation 3.03
20.4 Breaths per min
Standard Deviation 3.05
23.8 Breaths per min
Standard Deviation 4.82
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 9, n=5,4,5
19.2 Breaths per min
Standard Deviation 2.28
22.5 Breaths per min
Standard Deviation 3.79
22.0 Breaths per min
Standard Deviation 2.00
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 10, n=5,5,5
19.6 Breaths per min
Standard Deviation 2.61
18.0 Breaths per min
Standard Deviation 4.00
22.4 Breaths per min
Standard Deviation 1.67
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 11, n=5,3,4
19.6 Breaths per min
Standard Deviation 1.67
20.3 Breaths per min
Standard Deviation 3.21
25.0 Breaths per min
Standard Deviation 5.03
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 12, n=4,3,4
19.5 Breaths per min
Standard Deviation 1.00
20.0 Breaths per min
Standard Deviation 0.00
27.6 Breaths per min
Standard Deviation 11.52
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 13, n=4,4,4
19.5 Breaths per min
Standard Deviation 1.00
21.0 Breaths per min
Standard Deviation 2.16
23.0 Breaths per min
Standard Deviation 3.46
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 14, n=3,3,3
18.7 Breaths per min
Standard Deviation 1.15
22.7 Breaths per min
Standard Deviation 1.15
27.3 Breaths per min
Standard Deviation 7.57
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 15, n=3,3,3
18.0 Breaths per min
Standard Deviation 2.00
21.3 Breaths per min
Standard Deviation 1.15
24.0 Breaths per min
Standard Deviation 2.00
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 16, n=5,3,4
18.8 Breaths per min
Standard Deviation 3.35
20.0 Breaths per min
Standard Deviation 4.00
30.8 Breaths per min
Standard Deviation 16.88
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 17, n=2,0,3
18.0 Breaths per min
Standard Deviation 0.00
NA Breaths per min
Standard Deviation NA
No participants were analyzed for this parameter at this time point.
24.0 Breaths per min
Standard Deviation 4.00
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 18, n=3,3,4
19.3 Breaths per min
Standard Deviation 1.15
21.3 Breaths per min
Standard Deviation 3.06
29.0 Breaths per min
Standard Deviation 13.22
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 19, n=3,0,2
19.3 Breaths per min
Standard Deviation 1.15
NA Breaths per min
Standard Deviation NA
No participants were analyzed for this parameter at this time point.
28.0 Breaths per min
Standard Deviation 11.31
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 20, n=5,4,4
19.6 Breaths per min
Standard Deviation 1.67
21.5 Breaths per min
Standard Deviation 3.00
23.5 Breaths per min
Standard Deviation 3.42
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 21, n=3,2,5
19.3 Breaths per min
Standard Deviation 1.15
19.00 Breaths per min
Standard Deviation 1.41
23.6 Breaths per min
Standard Deviation 3.51
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 22, n=3,4,3
19.3 Breaths per min
Standard Deviation 2.31
21.0 Breaths per min
Standard Deviation 2.00
27.3 Breaths per min
Standard Deviation 7.57
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 23, n=4,2,4
20.0 Breaths per min
Standard Deviation 1.63
20.0 Breaths per min
Standard Deviation 0.00
21.5 Breaths per min
Standard Deviation 1.91
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
Week 24, n=5,5,4
19.6 Breaths per min
Standard Deviation 0.89
23.0 Breaths per min
Standard Deviation 3.16
24.8 Breaths per min
Standard Deviation 7.09
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
FU Week 2, n=3,2,0
19.3 Breaths per min
Standard Deviation 1.15
26.5 Breaths per min
Standard Deviation 9.19
NA Breaths per min
Standard Deviation NA
No participants were analyzed for this parameter at this time point.
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
FU Week 3, n=2,1,2
21.0 Breaths per min
Standard Deviation 4.24
28.0 Breaths per min
Standard Deviation NA
There were too few participants available to collect data at this time point to calculate a standard deviation.
24.5 Breaths per min
Standard Deviation 4.95
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
FU Week 4, n=1,0,1
18.0 Breaths per min
Standard Deviation NA
There were too few participants available to collect data at this time point to calculate a standard deviation.
NA Breaths per min
Standard Deviation NA
No participants were analyzed for this parameter at this time point.
24.0 Breaths per min
Standard Deviation NA
There were too few participants available to collect data at this time point to calculate a standard deviation.
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Dose-Finding Period, Part 1
MPB, n=5, 5, 5
24.4 Breaths per min
Standard Deviation 4.56
29.8 Breaths per min
Standard Deviation 6.02
32.2 Breaths per min
Standard Deviation 13.90

SECONDARY outcome

Timeframe: From Week 1 to Week 7 of Part 2

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X,X,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

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 value included any scheduled and unscheduled post-Baseline assessment.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=8 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=16 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=9 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
n=17 Participants
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
n=4 Participants
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
n=11 Participants
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2
BL, n= 5, 14, 9, 12, 3, 10
19.6 Breaths per min
Standard Deviation 1.67
18.4 Breaths per min
Standard Deviation 2.38
19.4 Breaths per min
Standard Deviation 3.13
21.5 Breaths per min
Standard Deviation 10.03
18.7 Breaths per min
Standard Deviation 1.15
21.4 Breaths per min
Standard Deviation 2.12
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2
Week 1, n=7, 16 ,9, 17, 2, 10
19.0 Breaths per min
Standard Deviation 1.00
18.8 Breaths per min
Standard Deviation 1.76
19.9 Breaths per min
Standard Deviation 2.26
20.7 Breaths per min
Standard Deviation 4.48
19.0 Breaths per min
Standard Deviation 1.41
28.2 Breaths per min
Standard Deviation 9.54
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2
Week 2, n=6, 15, 9, 16, 4, 10
19.3 Breaths per min
Standard Deviation 2.73
18.9 Breaths per min
Standard Deviation 2.70
19.8 Breaths per min
Standard Deviation 2.33
23.0 Breaths per min
Standard Deviation 8.01
21.5 Breaths per min
Standard Deviation 5.00
27.1 Breaths per min
Standard Deviation 11.70
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2
Week 3, n=8, 16, 9, 16, 4, 9
18.8 Breaths per min
Standard Deviation 1.83
18.9 Breaths per min
Standard Deviation 1.93
20.1 Breaths per min
Standard Deviation 2.76
22.3 Breaths per min
Standard Deviation 4.78
21.0 Breaths per min
Standard Deviation 2.58
25.8 Breaths per min
Standard Deviation 7.17
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2
Week 4, n=7, 16, 8, 14, 4, 10
19.4 Breaths per min
Standard Deviation 2.51
18.6 Breaths per min
Standard Deviation 2.80
19.8 Breaths per min
Standard Deviation 2.49
21.4 Breaths per min
Standard Deviation 4.29
21.5 Breaths per min
Standard Deviation 1.00
25.4 Breaths per min
Standard Deviation 7.18
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2
Week 5, n=8, 16, 8, 15, 3, 8
19.3 Breaths per min
Standard Deviation 1.04
18.5 Breaths per min
Standard Deviation 2.10
20.5 Breaths per min
Standard Deviation 2.98
19.7 Breaths per min
Standard Deviation 2.74
20.0 Breaths per min
Standard Deviation 2.00
29.0 Breaths per min
Standard Deviation 14.77
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2
Week 6, n=8, 16, 9, 15, 4, 9
20.3 Breaths per min
Standard Deviation 2.25
19.4 Breaths per min
Standard Deviation 2.16
20.6 Breaths per min
Standard Deviation 2.19
20.6 Breaths per min
Standard Deviation 4.12
21.0 Breaths per min
Standard Deviation 1.15
24.4 Breaths per min
Standard Deviation 6.69
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2
Week 7, n=7, 16, 9, 17, 4, 8
20.9 Breaths per min
Standard Deviation 2.27
18.4 Breaths per min
Standard Deviation 1.50
20.9 Breaths per min
Standard Deviation 3.33
20.7 Breaths per min
Standard Deviation 7.87
18.5 Breaths per min
Standard Deviation 1.91
23.5 Breaths per min
Standard Deviation 6.12
Mean Respiratory Rate at Baseline and the Maximum Post-Baseline Value Recorded During the Randomized Period, Part 2
MPB, n=8, 16, 9, 17, 4, 11
21.5 Breaths per min
Standard Deviation 2.33
21.3 Breaths per min
Standard Deviation 21.8
22.7 Breaths per min
Standard Deviation 2.45
26.6 Breaths per min
Standard Deviation 7.87
23.5 Breaths per min
Standard Deviation 3.42
30.0 Breaths per min
Standard Deviation 13.39

SECONDARY outcome

Timeframe: From Week 1 to Follow-up Week 4 of Part 2/3 up to Study Week 35

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.

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.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=24 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=26 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=15 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Screening, n=16, 14, 10
18.5 Breaths per minute
Standard Deviation 1.75
21.2 Breaths per minute
Standard Deviation 6.57
21.5 Breaths per minute
Standard Deviation 2.56
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Day 1 , n=21, 21, 15
19.2 Breaths per minute
Standard Deviation 2.57
2.12 Breaths per minute
Standard Deviation 7.74
21.7 Breaths per minute
Standard Deviation 4.76
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 1, n=24, 25, 14
19.1 Breaths per minute
Standard Deviation 1.74
20.4 Breaths per minute
Standard Deviation 3.93
25.1 Breaths per minute
Standard Deviation 7.63
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 2, n=22, 24, 13
19.4 Breaths per minute
Standard Deviation 2.56
21.8 Breaths per minute
Standard Deviation 6.85
25.2 Breaths per minute
Standard Deviation 10.83
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 3, n=24, 23, 12
18.8 Breaths per minute
Standard Deviation 1.73
21.2 Breaths per minute
Standard Deviation 4.40
24.0 Breaths per minute
Standard Deviation 6.09
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 4, n=23, 23, 13
19.0 Breaths per minute
Standard Deviation 2.59
20.9 Breaths per minute
Standard Deviation 3.82
24.3 Breaths per minute
Standard Deviation 6.37
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 5, n=23, 23, 11
18.9 Breaths per minute
Standard Deviation 2.13
19.8 Breaths per minute
Standard Deviation 3.19
26.9 Breaths per minute
Standard Deviation 12.91
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 6, n=23, 22, 11
19.3 Breaths per minute
Standard Deviation 2.30
20.6 Breaths per minute
Standard Deviation 4.11
23.3 Breaths per minute
Standard Deviation 4.92
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 7, n=22, 25, 11
18.8 Breaths per minute
Standard Deviation 1.99
20.1 Breaths per minute
Standard Deviation 4.46
22.4 Breaths per minute
Standard Deviation 4.60
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 8, n=19, 19, 10
19.2 Breaths per minute
Standard Deviation 2.32
23.4 Breaths per minute
Standard Deviation 6.23
22.0 Breaths per minute
Standard Deviation 1.79
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 9, n=17, 16, 12
19.5 Breaths per minute
Standard Deviation 2.96
22.0 Breaths per minute
Standard Deviation 3.95
22.5 Breaths per minute
Standard Deviation 4.48
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 10, n=16, 13, 11
18.7 Breaths per minute
Standard Deviation 2.27
22.8 Breaths per minute
Standard Deviation 3.83
23.3 Breaths per minute
Standard Deviation 6.83
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 11, n=15, 13, 12
18.9 Breaths per minute
Standard Deviation 1.28
22.8 Breaths per minute
Standard Deviation 3.11
22.2 Breaths per minute
Standard Deviation 5.29
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 12, n=17, 16, 9
18.6 Breaths per minute
Standard Deviation 1.90
22.2 Breaths per minute
Standard Deviation 3.76
23.6 Breaths per minute
Standard Deviation 4.98
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 13, n=11, 13, 8
19.3 Breaths per minute
Standard Deviation 1.56
23.4 Breaths per minute
Standard Deviation 7.68
21.0 Breaths per minute
Standard Deviation 2.62
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 14, n=13, 11, 7
18.7 Breaths per minute
Standard Deviation 2.98
19.9 Breaths per minute
Standard Deviation 5.49
23.4 Breaths per minute
Standard Deviation 4.86
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 15, n=12, 13, 5
18.7 Breaths per minute
Standard Deviation 1.76
21.1 Breaths per minute
Standard Deviation 2.53
24.4 Breaths per minute
Standard Deviation 8.76
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 16, n=16, 14, 8
18.6 Breaths per minute
Standard Deviation 1.26
22.9 Breaths per minute
Standard Deviation 7.97
24.3 Breaths per minute
Standard Deviation 6.88
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 17, n=13, 10, 5
19.0 Breaths per minute
Standard Deviation 2.08
22.4 Breaths per minute
Standard Deviation 6.45
25.2 Breaths per minute
Standard Deviation 9.65
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 18, n=16, 12, 4
19.1 Breaths per minute
Standard Deviation 3.79
22.0 Breaths per minute
Standard Deviation 4.53
29.0 Breaths per minute
Standard Deviation 10.52
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 19, n=14, 13, 6
18.1 Breaths per minute
Standard Deviation 1.49
24.5 Breaths per minute
Standard Deviation 19.33
24.0 Breaths per minute
Standard Deviation 6.45
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 20, n=13, 13, 7
17.4 Breaths per minute
Standard Deviation 1.94
20.9 Breaths per minute
Standard Deviation 3.52
33.00 Breaths per minute
Standard Deviation 16.77
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 21, n=4, 10, 3
18.8 Breaths per minute
Standard Deviation 3.40
20.2 Breaths per minute
Standard Deviation 3.55
28.0 Breaths per minute
Standard Deviation 10.58
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 22, n=11, 7, 5
19.7 Breaths per minute
Standard Deviation 2.94
19.1 Breaths per minute
Standard Deviation 2.79
26.0 Breaths per minute
Standard Deviation 4.90
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 23, n=8, 7, 6
20.4 Breaths per minute
Standard Deviation 2.72
21.1 Breaths per minute
Standard Deviation 3.24
23.7 Breaths per minute
Standard Deviation 5.13
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
Week 24, n=22, 23, 11
19.1 Breaths per minute
Standard Deviation 2.03
20.2 Breaths per minute
Standard Deviation 3.11
23.8 Breaths per minute
Standard Deviation 5.47
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
FU Week 1, n=6, 6, 3
18.8 Breaths per minute
Standard Deviation 1.60
20.0 Breaths per minute
Standard Deviation 3.41
26.0 Breaths per minute
Standard Deviation 10.39
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
FU Week 2, n=6, 5, 7
18.7 Breaths per minute
Standard Deviation 1.63
20.8 Breaths per minute
Standard Deviation 4.15
22.2 Breaths per minute
Standard Deviation 4.02
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
FU Week 3, n=6, 4, 4
19.0 Breaths per minute
Standard Deviation 1.67
23.0 Breaths per minute
Standard Deviation 4.16
24.8 Breaths per minute
Standard Deviation 5.50
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
FU Week 4, n=10, 12, 7
19.4 Breaths per minute
Standard Deviation 0.97
20.8 Breaths per minute
Standard Deviation 1.86
21.0 Breaths per minute
Standard Deviation 3.74
Mean Respiratory Rate at Baseline and Maximum Post-Baseline Visit During Part 2/3
MPB, n=24, 26, 15
23.0 Breaths per minute
Standard Deviation 2.78
27.7 Breaths per minute
Standard Deviation 13.00
27.7 Breaths per minute
Standard Deviation 11.54

SECONDARY outcome

Timeframe: From Week 1 to Follow-up Week 4 of Part 1, up to Study Week 28

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

Pulse 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 (MPB) visit included any scheduled and unscheduled post-Baseline assessment..

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=5 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 16, n=5, 3, 4
86.4 Beats per minute
Standard Deviation 18.60
103.0 Beats per minute
Standard Deviation 5.57
93.0 Beats per minute
Standard Deviation 18.96
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 17, n=2, 0, 3
67.5 Beats per minute
Standard Deviation 20.51
NA Beats per minute
Standard Deviation NA
There were no participants analyzed at this time point, therefore there is no calculated standard deviation.
97.7 Beats per minute
Standard Deviation 12.01
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 18, n=3, 3, 4
88.0 Beats per minute
Standard Deviation 10.44
86.7 Beats per minute
Standard Deviation 17.01
102.8 Beats per minute
Standard Deviation 16.88
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 19, n=3, 0, 2
88.0 Beats per minute
Standard Deviation 20.81
NA Beats per minute
Standard Deviation NA
There were no participants analyzed at this time point, therefore there is no calculated standard deviation.
94.0 Beats per minute
Standard Deviation 8.49
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 20, n=5, 4, 4
79.8 Beats per minute
Standard Deviation 13.03
96.8 Beats per minute
Standard Deviation 12.58
111.8 Beats per minute
Standard Deviation 14.97
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 21, n=3, 2, 5
79.0 Beats per minute
Standard Deviation 6.93
75.5 Beats per minute
Standard Deviation 3.54
101.0 Beats per minute
Standard Deviation 18.63
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 22, n=3, 4, 4
70.3 Beats per minute
Standard Deviation 14.36
86.5 Beats per minute
Standard Deviation 9.04
100.0 Beats per minute
Standard Deviation 18.63
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 23, n=4, 2, 5
71.5 Beats per minute
Standard Deviation 13.03
82.5 Beats per minute
Standard Deviation 3.54
100.0 Beats per minute
Standard Deviation 13.14
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 24, n=5, 5, 5
79.6 Beats per minute
Standard Deviation 7.86
85.8 Beats per minute
Standard Deviation 6.91
96.0 Beats per minute
Standard Deviation 4.74
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
FU Week 1, n=1, 1, 3
81.0 Beats per minute
Standard Deviation NA
There were too few participants available to collect data at this time point to calculate a standard deviation.
125.0 Beats per minute
Standard Deviation NA
There were too few participants available to collect data at this time point to calculate a standard deviation.
107.7 Beats per minute
Standard Deviation 10.79
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
FU Week 2, n=3, 2, 0
77.7 Beats per minute
Standard Deviation 8.74
84.5 Beats per minute
Standard Deviation 28.99
NA Beats per minute
Standard Deviation NA
There were no participants analyzed at this time point, therefore there is no calculated standard deviation.
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
FU Week 3, n=2, 1, 2
87.0 Beats per minute
Standard Deviation 2.83
78.0 Beats per minute
Standard Deviation NA
There were too few participants available to collect data at this time point to calculate a standard deviation.
98.0 Beats per minute
Standard Deviation 8.49
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
FU Week 4, n=1, 0, 2
89.0 Beats per minute
Standard Deviation NA
There were too few participants available to collect data at this time point to calculate a standard deviation.
NA Beats per minute
Standard Deviation NA
There were no participants analyzed at this time point, therefore there is no calculated standard deviation.
99.0 Beats per minute
Standard Deviation 26.87
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
MBP, n=5, 5, 5
108.8 Beats per minute
Standard Deviation 24.01
109.8 Beats per minute
Standard Deviation 14.17
119.6 Beats per minute
Standard Deviation 5.73
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Screening, n=5, 5, 5
85.2 Beats per minute
Standard Deviation 15.71
88.4 Beats per minute
Standard Deviation 8.50
102.0 Beats per minute
Standard Deviation 7.97
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Day 1, n=4, 5, 5,
84.3 Beats per minute
Standard Deviation 11.32
88.2 Beats per minute
Standard Deviation 12.89
102.4 Beats per minute
Standard Deviation 13.22
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 1, n= 4, 5, 5
85.3 Beats per minute
Standard Deviation 4.79
90.8 Beats per minute
Standard Deviation 11.19
103.8 Beats per minute
Standard Deviation 8.47
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 2, n=5, 5, 5
80.4 Beats per minute
Standard Deviation 12.97
84.4 Beats per minute
Standard Deviation 16.77
96.8 Beats per minute
Standard Deviation 10.66
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 3, n=5, 5, 5
92.8 Beats per minute
Standard Deviation 31.16
91.4 Beats per minute
Standard Deviation 11.04
106.2 Beats per minute
Standard Deviation 11.10
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 4, n=5, 5, 5
86.4 Beats per minute
Standard Deviation 10.92
84.0 Beats per minute
Standard Deviation 7.62
98.6 Beats per minute
Standard Deviation 14.29
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 5, n=5, 5, 5
84.6 Beats per minute
Standard Deviation 9.48
88.4 Beats per minute
Standard Deviation 9.58
107.8 Beats per minute
Standard Deviation 9.58
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 6, n=5, 5, 4
76.4 Beats per minute
Standard Deviation 10.50
89.8 Beats per minute
Standard Deviation 13.79
103.0 Beats per minute
Standard Deviation 8.29
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 7, n=5, 5, 5
82.0 Beats per minute
Standard Deviation 9.46
96.2 Beats per minute
Standard Deviation 17.84
103.2 Beats per minute
Standard Deviation 8.93
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 8, n=5, 5, 5
83.0 Beats per minute
Standard Deviation 5.20
89.4 Beats per minute
Standard Deviation 15.04
111.8 Beats per minute
Standard Deviation 10.62
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 9, n=5, 5, 5
80.4 Beats per minute
Standard Deviation 13.35
79.2 Beats per minute
Standard Deviation 11.34
101.6 Beats per minute
Standard Deviation 5.59
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 10, n=5, 5, 5
80.6 Beats per minute
Standard Deviation 14.93
84.4 Beats per minute
Standard Deviation 10.31
105.4 Beats per minute
Standard Deviation 9.29
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 11, n=5, 3, 5
86.6 Beats per minute
Standard Deviation 11.04
97.7 Beats per minute
Standard Deviation 16.50
106.6 Beats per minute
Standard Deviation 11.19
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 12, n=4, 4, 5
80.5 Beats per minute
Standard Deviation 12.07
92.0 Beats per minute
Standard Deviation 12.83
101.4 Beats per minute
Standard Deviation 16.62
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 13, n=4, 4, 4
90.8 Beats per minute
Standard Deviation 15.52
86.5 Beats per minute
Standard Deviation 7.05
103.8 Beats per minute
Standard Deviation 3.50
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 14, n=3, 3, 3
81.0 Beats per minute
Standard Deviation 9.85
87.0 Beats per minute
Standard Deviation 8.66
101.0 Beats per minute
Standard Deviation 11.00
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Dose-Finding Period, Part 1
Week 15, n=3, 4, 4
77.3 Beats per minute
Standard Deviation 6.66
86.8 Beats per minute
Standard Deviation 11.87
102.5 Beats per minute
Standard Deviation 3.87

SECONDARY outcome

Timeframe: From Week 1 to Week 7 of Part 2

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 ITT Population.

Pulse 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.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=8 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=16 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=9 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
n=17 Participants
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
n=4 Participants
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
n=11 Participants
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2
Screening, n=8, 16, 9, 15
80.1 Beats per minute
Standard Deviation 10.11
82.8 Beats per minute
Standard Deviation 17.28
86.9 Beats per minute
Standard Deviation 16.10
94.3 Beats per minute
Standard Deviation 17.53
91.5 Beats per minute
Standard Deviation 6.56
101.5 Beats per minute
Standard Deviation 23.48
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2
Day 1, n=6, 14, 9, 13
77.2 Beats per minute
Standard Deviation 12.32
81.3 Beats per minute
Standard Deviation 8.70
93.0 Beats per minute
Standard Deviation 14.04
88.8 Beats per minute
Standard Deviation 12.84
98.7 Beats per minute
Standard Deviation 5.69
99.6 Beats per minute
Standard Deviation 15.84
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2
Week 1, n=8, 16, 9, 17
76.4 Beats per minute
Standard Deviation 8.50
80.1 Beats per minute
Standard Deviation 12.04
89.9 Beats per minute
Standard Deviation 18.48
98.4 Beats per minute
Standard Deviation 19.76
98.5 Beats per minute
Standard Deviation 13.44
96.4 Beats per minute
Standard Deviation 17.08
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2
Week 2, n=7, 15, 9, 17
79.4 Beats per minute
Standard Deviation 8.75
81.7 Beats per minute
Standard Deviation 9.79
89.0 Beats per minute
Standard Deviation 12.44
91.8 Beats per minute
Standard Deviation 16.96
95.3 Beats per minute
Standard Deviation 7.09
102.5 Beats per minute
Standard Deviation 11.81
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2
Week 3, n=8, 16, 9, 16
81.5 Beats per minute
Standard Deviation 12.21
84.0 Beats per minute
Standard Deviation 10.93
86.6 Beats per minute
Standard Deviation 13.39
95.8 Beats per minute
Standard Deviation 13.57
97.0 Beats per minute
Standard Deviation 14.67
102.6 Beats per minute
Standard Deviation 17.44
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2
Week 4, n=8, 16, 9, 16
76.3 Beats per minute
Standard Deviation 6.96
82.4 Beats per minute
Standard Deviation 10.39
84.4 Beats per minute
Standard Deviation 15.91
91.5 Beats per minute
Standard Deviation 14.45
93.5 Beats per minute
Standard Deviation 17.00
116.1 Beats per minute
Standard Deviation 23.26
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2
Week 5, n=8, 16, 9, 16
79.3 Beats per minute
Standard Deviation 9.44
82.5 Beats per minute
Standard Deviation 13.87
95.3 Beats per minute
Standard Deviation 14.96
92.4 Beats per minute
Standard Deviation 15.18
89.0 Beats per minute
Standard Deviation 15.52
99.8 Beats per minute
Standard Deviation 19.51
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2
Week 6, n=8, 16, 9, 17
77.0 Beats per minute
Standard Deviation 9.50
83.2 Beats per minute
Standard Deviation 11.01
86.8 Beats per minute
Standard Deviation 11.62
90.1 Beats per minute
Standard Deviation 17.74
84.8 Beats per minute
Standard Deviation 13.15
103.0 Beats per minute
Standard Deviation 23.14
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2
Week 7, n=8, 16, 9, 17
74.1 Beats per minute
Standard Deviation 6.92
82.8 Beats per minute
Standard Deviation 11.68
96.7 Beats per minute
Standard Deviation 15.39
91.6 Beats per minute
Standard Deviation 17.68
101.5 Beats per minute
Standard Deviation 16.60
105.3 Beats per minute
Standard Deviation 15.18
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Randomized Period, Part 2
MBP, n=8, 16, 9, 17
88.3 Beats per minute
Standard Deviation 7.72
97.6 Beats per minute
Standard Deviation 7.51
106.1 Beats per minute
Standard Deviation 11.92
108.6 Beats per minute
Standard Deviation 17.08
106.8 Beats per minute
Standard Deviation 12.28
117.5 Beats per minute
Standard Deviation 21.68

SECONDARY outcome

Timeframe: From Week 1to Follow-up Week 4 of Part 2/3, up to Study Week 35

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.

Pulse 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.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=24 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=26 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=15 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 11, n=15, 14, 12
81.5 Beats per minute
Standard Deviation 10.20
89.3 Beats per minute
Standard Deviation 16.28
99.3 Beats per minute
Standard Deviation 15.39
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 12, n=17, 16, 9
81.1 Beats per minute
Standard Deviation 11.98
91.1 Beats per minute
Standard Deviation 16.39
105.3 Beats per minute
Standard Deviation 19.58
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 13, n=11, 13, 8
78.1 Beats per minute
Standard Deviation 8.47
97.0 Beats per minute
Standard Deviation 21.79
99.5 Beats per minute
Standard Deviation 20.57
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 14, n=13, 12, 7
74.5 Beats per minute
Standard Deviation 11.15
94.8 Beats per minute
Standard Deviation 18.07
95.6 Beats per minute
Standard Deviation 12.09
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 15, n=12, 14, 5
82.5 Beats per minute
Standard Deviation 9.41
94.4 Beats per minute
Standard Deviation 18.94
98.0 Beats per minute
Standard Deviation 8.72
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Screening, n=16, 15, 10
82.8 Beats per minute
Standard Deviation 17.28
94.3 Beats per minute
Standard Deviation 17.53
104.8 Beats per minute
Standard Deviation 21.82
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Day 1 , n=22, 22, 15
78.7 Beats per minute
Standard Deviation 8.67
92.0 Beats per minute
Standard Deviation 14.14
100.8 Beats per minute
Standard Deviation 15.71
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 1, n=24, 26, 14
79.9 Beats per minute
Standard Deviation 10.82
94.8 Beats per minute
Standard Deviation 17.54
97.8 Beats per minute
Standard Deviation 15.67
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 2, n=23, 26, 13
79.9 Beats per minute
Standard Deviation 10.02
92.5 Beats per minute
Standard Deviation 16.91
99.8 Beats per minute
Standard Deviation 12.64
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 3, n=24, 24, 12
83.3 Beats per minute
Standard Deviation 10.63
95.4 Beats per minute
Standard Deviation 12.31
99.4 Beats per minute
Standard Deviation 16.56
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 4, n=24, 25, 13
81.9 Beats per minute
Standard Deviation 9.81
91.7 Beats per minute
Standard Deviation 13.42
110.6 Beats per minute
Standard Deviation 22.55
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 5, n=24, 24, 11
80.8 Beats per minute
Standard Deviation 13.00
91.7 Beats per minute
Standard Deviation 14.72
97.4 Beats per minute
Standard Deviation 17.92
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 6, n=23, 24, 11
82.2 Beats per minute
Standard Deviation 10.45
91.6 Beats per minute
Standard Deviation 16.82
102.8 Beats per minute
Standard Deviation 20.31
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 7, n=22, 25, 11
82.1 Beats per minute
Standard Deviation 11.47
91.1 Beats per minute
Standard Deviation 16.61
101.5 Beats per minute
Standard Deviation 16.91
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 8, n=19, 20, 10
79.9 Beats per minute
Standard Deviation 11.85
90.8 Beats per minute
Standard Deviation 16.68
94.2 Beats per minute
Standard Deviation 25.71
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 9, n=17, 16, 12
87.4 Beats per minute
Standard Deviation 15.75
91.9 Beats per minute
Standard Deviation 17.79
100.9 Beats per minute
Standard Deviation 15.19
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 10, n=16, 13, 11
87.9 Beats per minute
Standard Deviation 11.74
94.3 Beats per minute
Standard Deviation 17.82
97.8 Beats per minute
Standard Deviation 18.77
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 16, n=17, 14, 8v
81.3 Beats per minute
Standard Deviation 11.24
91.4 Beats per minute
Standard Deviation 15.08
99.8 Beats per minute
Standard Deviation 17.16
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 17, n=13, 11, 5
79.7 Beats per minute
Standard Deviation 11.69
96.1 Beats per minute
Standard Deviation 20.80
102.2 Beats per minute
Standard Deviation 22.61
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 18, n=16, 12, 4
81.1 Beats per minute
Standard Deviation 8.79
95.8 Beats per minute
Standard Deviation 23.01
99.8 Beats per minute
Standard Deviation 5.56
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 19, n=14, 14, 6
82.1 Beats per minute
Standard Deviation 12.33
96.5 Beats per minute
Standard Deviation 20.24
104.2 Beats per minute
Standard Deviation 18.88
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 20, n=13, 13, 7
79.0 Beats per minute
Standard Deviation 10.98
95.9 Beats per minute
Standard Deviation 17.44
91.6 Beats per minute
Standard Deviation 17.18
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 21, n=4, 10, 3
82.3 Beats per minute
Standard Deviation 10.53
90.3 Beats per minute
Standard Deviation 10.71
99.7 Beats per minute
Standard Deviation 15.28
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 22, n=11, 6, 5
83.2 Beats per minute
Standard Deviation 10.57
99.7 Beats per minute
Standard Deviation 5.50
98.6 Beats per minute
Standard Deviation 18.20
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 23, n=8, 7, 6
80.4 Beats per minute
Standard Deviation 11.25
89.0 Beats per minute
Standard Deviation 22.38
96.2 Beats per minute
Standard Deviation 10.68
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
Week 24, n=23, 23, 11
81.2 Beats per minute
Standard Deviation 9.70
93.5 Beats per minute
Standard Deviation 12.59
95.3 Beats per minute
Standard Deviation 17.75
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
FU Week 1, n=6, 6, 3
86.3 Beats per minute
Standard Deviation 5.85
94.2 Beats per minute
Standard Deviation 18.03
100.0 Beats per minute
Standard Deviation 20.07
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
FU Week 2, n=8, 7, 7
83.0 Beats per minute
Standard Deviation 8.54
87.9 Beats per minute
Standard Deviation 12.77
110.0 Beats per minute
Standard Deviation 27.47
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
FU Week 3, n=6, 5, 4
83.7 Beats per minute
Standard Deviation 13.03
92.4 Beats per minute
Standard Deviation 11.55
92.0 Beats per minute
Standard Deviation 12.19
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
FU Week 4, n=11, 13, 7
81.6 Beats per minute
Standard Deviation 11.89
92.3 Beats per minute
Standard Deviation 16.10
102.3 Beats per minute
Standard Deviation 18.87
Mean Pulse Rate at Baseline and the Maximum Post-Baseline Visit Recorded During the Eltrombopag Only Period Part 2/3
MPB, n=24, 26, 15
102.2 Beats per minute
Standard Deviation 9.35
110.9 Beats per minute
Standard Deviation 15.03
121.2 Beats per minute
Standard Deviation 20.42

SECONDARY outcome

Timeframe: Baseline and Week 24 of Part 1

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=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.

Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 24 (W24). The Baseline value was the measurement taken at Day 1.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=15 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, MS, BL, n=3
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, NR, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, Neg, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, Trace, BL, n=3
2 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, 1+, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, 2+, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, 3+, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, 4+, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, MS, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, NR, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, Neg, BL, n=3
3 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, normal, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, 5, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, 15(1+), BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, 30(2+), BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, 60(3+), BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, 110(4+), BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, MS, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, NR, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, Neg, BL, n=3
3 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, Trace(5), BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, Small(15), BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, Moderate(40), BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, Large(80), BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, Large(160), BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, MS, BL,n=3
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, NR, BL,n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, Neg, BL,n=3
2 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, 1+, BL,n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, 2+, BL,n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, 3+, BL,n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, Non haemolysed trace, BL,n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, haemolysed trace, BL,n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, MS, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, NR, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, normal result, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, Neg, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 5, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 5.5, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 6, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 6.5, BL, n=3
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 7, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 7.5,BL, n=3
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 8, BL, n=3
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 8.5, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 9, BL, n=3
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, MS, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, NR, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, Neg, W24, n=4
3 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, Trace, W24, n=4
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, 1+, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, 2+, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, 3+, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UP, 4+, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, MS, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, NR, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, Neg, W24, n=4
4 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, normal, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, 5, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, 15(1+), W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, 30(2+), W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, 60(3+), W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UG, 110(4+), W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, MS, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, NR, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, Neg, W24, n=4
3 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, Trace(5), W24, n=4
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, Small(15), W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, Moderate(40), W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, Large(80), W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UK, Large(160), W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, MS, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, NR, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, Neg, W24, n=4
3 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, 1+, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, 2+, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, 3+, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, Non haemolysed trace, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
UOB, haemolysed trace, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, MS, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, NR, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, normal result, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, Neg, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 5, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 5.5, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 6, W24, n=4
2 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 6.5, W24, n=4
2 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 7, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 7.5,W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 8, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 8.5, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Dose-Finding Period, Part 1
pH, 9, W24, n=4
0 Participants

SECONDARY outcome

Timeframe: Baseline and Week 7 of Part 2

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=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

Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 7 (W7). The Baseline value was the measurement taken at Day 1.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=21 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=44 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, MS, BL, n=10, 9
2 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, NR, BL, n=10, 9
0 Participants
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, Neg, BL, n=10, 9
7 Participants
8 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, Trace, BL, n=10, 9
1 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, 1+, BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, 2+, BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, 3+, BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, 4+, BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, MS, BL, n=10, 9
2 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, NR, BL, n=10, 9
0 Participants
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, Neg, BL, n=10, 9
6 Participants
8 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, normal, BL, n=10, 9
2 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, 5, BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, 15(1+), BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, 30(2+), BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, 60(3+), BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, 110(4+), BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, MS, BL, n=10, 9
2 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, NR, BL, n=10, 9
0 Participants
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, Neg, BL, n=10, 9
8 Participants
8 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, Trace(5), BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, Small(15), BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, Moderate(40), BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, Large(80), BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, Large(160), BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, MS, BL, n=9, 9
2 Participants
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, NR, BL, n=9, 9
0 Participants
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, Neg, BL, n=9, 9
6 Participants
4 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, 1+, BL,n=9, 9
0 Participants
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, 2+, BL,n=9, 9
1 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, 3+, BL, n=9, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, Non haemolysed trace, BL,n=9, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, haemolysed trace, BL, n=9, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, MS, BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, NR, BL, n=10, 9
0 Participants
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, normal result, BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, Neg, BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 5, BL, n=10, 9
1 Participants
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 5.5, BL, n=10, 9
1 Participants
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 6, BL, n=10, 9
3 Participants
4 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 6.5, BL, n=10, 9
2 Participants
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 7, BL, n=10, 9
1 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 7.5,BL, n=10, 9
1 Participants
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 8, BL, n=10, 9
1 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 8.5, BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 9, BL, n=10, 9
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, MS, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, NR, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, Neg, W7, n=2, 3
2 Participants
3 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, Trace, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, 1+, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, 2+, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, 3+, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UP, 4+, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, MS, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, NR, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, Neg, W7, n=2, 3
2 Participants
3 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, normal, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, 5, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, 15(1+), W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, 30(2+), W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, 60(3+), W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UG, 110(4+), W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, MS, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, NR, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, Neg, W7, n=2, 3
2 Participants
3 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, Trace(5), W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, Small(15), W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, Moderate(40), W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, Large(80), W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UK, Large(160), W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, MS, W7, n=2, 3
1 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, NR, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, Neg, W7, n=2, 3
1 Participants
3 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, 1+, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, 2+, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, 3+, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, Non haemolysed trace, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
UOB, haemolysed trace, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, MS, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, NR, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, normal result, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, Neg, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 5, W7, n=2, 3
1 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 5.5, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 6, W7, n=2, 3
0 Participants
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 6.5, W7, n=2, 3
0 Participants
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 7, W7, n=2, 3
1 Participants
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 7.5, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 8, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 8.5, W7, n=2, 3
0 Participants
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 7 During the Randomized Period,Part 2
pH, 9, W7, n=2, 3
0 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline and Week 24 of Part 2/3 up to Study Week 31

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=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

Urinalysis parameters included: urine protein (UP), urine glucose (UG), urine ketones (UK), urine occult blood (UOB), and pH. The dipstick test gives results in a semi-quantitative manner. UP was categorized as missing (MS), no result (NR), negative (Neg), Trace, 1+, 2+, 3+ and 4+. UG results were categorized as MS, NR, Neg, normal, 5, 15(1+), 30(2+), 60(3+), 110(4+)UK parameters were categorized as as MS, NR, Neg, Trace(5), Small(15), Moderate(40), Large(80), Large(160). UOB parameters were categorized as MS, NR, Neg, 1+, 2+, 3+, Non haemolysed trace, and haemolysed trace. PH results were categorized as MS. NR, normalresult, Neg, and range of pH (from 5-9in increments of 0.5). Data for indicated parameters was reported at Baseline (BL) and Week 24 (W24). The Baseline value was the measurement taken at Day 1.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=44 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, MS, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, NR, BL, n=11
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, Neg, BL, n=11
10 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, Trace, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, 1+, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, 2+, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, 3+, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, 4+, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, MS, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, NR, BL, n=11
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, Neg, BL, n=11
10 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, normal, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, 5, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, 15(1+), BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, 30(2+), BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, 60(3+), BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, 110(4+), BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, MS, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, NR, BL, n=11
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, Neg, BL, n=11
10 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, Trace(5), BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, Small(15), BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, Moderate(40), BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, Large(80), BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, Large(160), BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, MS, BL,n=11
2 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, NR, BL,n=11
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, Neg, BL,n=11
5 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, 1+, BL,n=11
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, 2+, BL,n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, 3+, BL,n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, Non haemolysed trace, BL,n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, haemolysed trace, BL,n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, MS, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, NR, BL, n=11
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, normal result, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, Neg, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 5, BL, n=11
2 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 5.5, BL, n=11
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 6, BL, n=11
4 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 6.5, BL, n=11
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 7, BL, n=11
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 7.5,BL, n=11
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 8, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 8.5, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 9, BL, n=11
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, MS, W24, n=34
2 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, NR, W24, n=34
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, Neg, W24, n=34
32 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, Trace, W24, n=34
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, 1+, W24, n=34
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, 2+, W24, n=34
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, 3+, W24, n=34
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UP, 4+, W24, n=34
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, MS, W24, n=4
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, NR, W24, n=4
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, Neg, W24, n=33
29 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, normal, W24, n=33
3 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, 5, W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, 15(1+), W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, 30(2+), W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, 60(3+), W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UG, 110(4+), W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, MS, W24, n=33
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, NR, W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, Neg, W24, n=33
32 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, Trace(5), W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, Small(15), W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, Moderate(40), W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, Large(80), W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UK, Large(160), W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, MS, W24, n=33
1 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, NR, W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, Neg, W24, n=33
31 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, 1+, W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, 2+, W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, 3+, W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, Non haemolysed trace, W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
UOB, haemolysed trace, W24, n=33
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, MS, W24, n=34
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, NR, W24, n=34
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, normal result, W24, n=34
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, Neg, W24, n=34
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 5, W24, n=34
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 5.5, W24, n=34
4 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 6, W24, n=34
10 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 6.5, W24, n=34
4 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 7, W24, n=34
11 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 7.5,W24, n=34
3 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 8, W24, n=34
2 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 8.5, W24, n=34
0 Participants
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 24 During the Eltrombopag Open-label Period, Part 2/3
pH, 9, W24, n=34
0 Participants

SECONDARY outcome

Timeframe: From Treatment + 1 day up to Week 24 of Part1

Population: Safety Population: all participants who received at least one dose of the investigational product during Part 1 were analyzed.

An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=5 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1
Any AE
5 Participants
5 Participants
5 Participants
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 1
Any SAE
1 Participants
1 Participants
0 Participants

SECONDARY outcome

Timeframe: From Treatment + 1 day up to Week 7 of Part 2

Population: Safety Population: all participants who received at least one dose of the investigational product during Part 2 were analyzed.

An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=8 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=16 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=9 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
n=17 Participants
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
n=4 Participants
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
n=11 Participants
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2
Any AE
8 Participants
13 Participants
9 Participants
14 Participants
3 Participants
9 Participants
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2
Any SAE
1 Participants
1 Participants
1 Participants
3 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: From Treatment + 1 day up to Week 31 of Part2/3

Population: Safety Population: all participants who received at least one dose of the investigational product during Part 2/3 were analyzed

An adverse event (AE) is defined as any untoward medical occurrence in a participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability or incapacity, or is a congenital anomaly or birth defect. Medical or scientific judgment should be exercised in other situations.

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=24 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=26 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=15 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3
Any AE
22 Participants
26 Participants
14 Participants
Number of Participants With Any Adverse Event (AE) or Serious Adverse Event (SAE) During Part 2/3
Any SAE
3 Participants
5 Participants
0 Participants

SECONDARY outcome

Timeframe: Baseline, 3and 6-mo Follow-up of Part 1

Population: Safety Population: all subjects who have received at least one dose of the investigational product during Part 1 were analyzed.

The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. The number of participants with a change in visual acuity and worsening visual acuity due to cataracts since Baseline are presented for Part 1 Follow-up Visits at 3-months (FU3) and at 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as "yes" or "no". Change due to cataracts is categorized as "yes" or "no".

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=5 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=5 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1
Change in VA at FU3, no
1 Participants
1 Participants
2 Participants
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1
Change in VA at FU3, yes
0 Participants
0 Participants
1 Participants
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1
Change in VA at FU6, no
4 Participants
4 Participants
5 Participants
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1
Change in VA at FU6, yes
0 Participants
0 Participants
0 Participants
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1
Change due to cataracts at FU3, no
0 Participants
0 Participants
1 Participants
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1
Change due to cataracts at FU3, yes
0 Participants
0 Participants
0 Participants
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1
Change due to cataracts at FU6, no
0 Participants
0 Participants
0 Participants
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts During Part 1
Change due to cataracts at FU6, yes
0 Participants
0 Participants
0 Participants

SECONDARY outcome

Timeframe: BL, 3 and 6mo Follow-up of Part 2/3

Population: Safety Population: all subjects who have received at least one dose of the investigational product during Part 2/3 were analyzed.

The visual acuity assessment was performed by an ophthalmologist or an optometrist under the guidance of an ophthalmologist. Visual acuity is defined as acuteness or clearness of vision. Number of participants with a change in visual acuity and change in visual acuity due to the worsening of cataracts since Baseline are presented for Part 2/3 Follow-up Visits at 3-months (FU3) and 6-months (FU6). Change in visual acuity since Baseline is displayed under the left eye but applies to both eyes. Change in visual acuity (VA) is categorized as "yes" or "no". Change due to cataracts is categorized as "yes" or "no".

Outcome measures

Outcome measures
Measure
Part 2 (Randomized Period) Cohort 1-Placebo
n=24 Participants
Participants aged between 12 and 17 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 1- Eltrombopag
n=26 Participants
Participants aged between 12 and 17 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was 37.5 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 2-Placebo
n=15 Participants
Participants aged between 6 and 11 years received eltrombopag matching placebo administered as a tablet QD for 7 weeks.
Part 2 (Randomized Period) Cohort 2-Eltrombopag
Participants aged between 6 and 11 years received eltrombopag administered as a tablet for 7 weeks. The starting dose of eltrombopag was based on the body weight, participants with a weight of \<27 kg received 25 mg QD and participants with a weight of \>=27 kg received 50 mg QD. Participants of East Asian ancestry with a body weight of \<27 kg received 12.5 mg QD and participants with a weight of \>=27 kg received 25 mg QD. The maximum dose allowed was 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Part 2 (Randomized Period) Cohort 3-Placebo
Participants aged between 1 to 5 years received eltrombopag matching placebo administered as a dry powder for oral suspension QD for 7 weeks.
Part 2 (Randomized Period) Cohort 3- Eltrombopag
Participants aged between 1 to 5 years received eltrombopag administered as a dry powder for oral suspension for 7 weeks. The starting dose of eltrombopag was 1.5 mg/kg QD and the dose calculations were based on the body weight. Participants of East Asian ancestry began at 0.8 mg/kg/day. The maximum dose allowed was 2 mg/kg, unless otherwise approved by the investigator, and could not exceed 75 mg daily. All participants enrolled in the study underwent individual dose titration based upon platelet response.
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts
Change due to cataracts at FU3, no
4 Participants
1 Participants
2 Participants
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts
Change due to cataracts at FU3, yes
0 Participants
0 Participants
0 Participants
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts
Change due to cataracts at FU6, no
4 Participants
2 Participants
3 Participants
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts
Change due to cataracts at FU6, yes
0 Participants
0 Participants
0 Participants
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts
Change in VA at FU6, no
16 Participants
22 Participants
6 Participants
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts
Change in VA at FU6, yes
4 Participants
2 Participants
3 Participants
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts
Change in VA at FU3, no
13 Participants
17 Participants
9 Participants
Number of Participants With a Change in Visual Acuity and a Change Due to Worsening of Cataracts
Change in VA at FU3, yes
4 Participants
1 Participants
2 Participants

Adverse Events

Part 1 (Dose-Finding Period)

Serious events: 2 serious events
Other events: 15 other events
Deaths: 0 deaths

Part 2 (Randomized Period) -Placebo

Serious events: 2 serious events
Other events: 20 other events
Deaths: 0 deaths

Part 2 (Randomized Period) - Eltrombopag

Serious events: 4 serious events
Other events: 36 other events
Deaths: 0 deaths

Part 2/ 3 (Eltrombopag Open-Label Period)

Serious events: 8 serious events
Other events: 62 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Part 1 (Dose-Finding Period)
n=15 participants at risk
Participants 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 eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight \<27 kg: 25 mg QD, Weight \>=27 kg: 50 mg QD; east Asian ancestry subjects Weight \<27 kg: 12.5 mg QD, Weight \>=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
Part 2 (Randomized Period) -Placebo
n=21 participants at risk
Participants 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
n=44 participants at risk
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)
n=65 participants at risk
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. Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2.
Blood and lymphatic system disorders
Neutropenia
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Respiratory, thoracic and mediastinal disorders
Epistaxis
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Blood and lymphatic system disorders
Anaemia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Blood and lymphatic system disorders
Febrile neutropenia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
General disorders
Pyrexia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Urinary tract infection
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Impetigo
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Varicella
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Eye disorders
Conjunctivitis
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Eye disorders
Lenticular opacities
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Eye disorders
Vitreous opacities
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
Alanine aminotransferase increased
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.

Other adverse events

Other adverse events
Measure
Part 1 (Dose-Finding Period)
n=15 participants at risk
Participants 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 eltrombopag 25 mg, (East Asian ancestry: 12.5mg, QD). For cohort 2 starting dose was based on the body weight (Weight \<27 kg: 25 mg QD, Weight \>=27 kg: 50 mg QD; east Asian ancestry subjects Weight \<27 kg: 12.5 mg QD, Weight \>=27 kg: 25 mg QD). For cohort 1 and 2 maximum dose allowed was 75mg. For cohort 3 starting dose was 0.7 mg/kg, QD and the dose calculations were based on the body weight. For all participants individual dose titration was allowed based upon platelet response.
Part 2 (Randomized Period) -Placebo
n=21 participants at risk
Participants 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
n=44 participants at risk
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)
n=65 participants at risk
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. Par who received placebo during the Randomized Period followed the starting doses for each age Cohort specified for Part 2.
Gastrointestinal disorders
Vomiting
40.0%
6/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
28.6%
6/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
9.1%
4/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
15.4%
10/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Diarrhoea
33.3%
5/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
15.9%
7/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
26.2%
17/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Abdominal pain
13.3%
2/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
9.5%
2/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
6.8%
3/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
23.1%
15/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Abdominal pain upper
13.3%
2/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.5%
2/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
9.2%
6/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Toothache
13.3%
2/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
6.8%
3/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
6.2%
4/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Gingival bleeding
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
9.5%
2/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Haematochezia
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Nausea
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
28.6%
6/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
13.6%
6/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
23.1%
15/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Stomatitis
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Abdominal discomfort
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.5%
2/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.6%
3/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Breath odour
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Constipation
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
9.2%
6/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Dyspepsia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Oral pain
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Mouth ulceration
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.6%
3/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Mouth haemorrhage
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Tongue discolouration
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Abdominal distension
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Anal ulcer
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Melaena
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Gastrointestinal disorders
Tooth loss
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Upper respiratory tract infection
33.3%
5/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
9.5%
2/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
25.0%
11/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
36.9%
24/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Nasopharyngitis
13.3%
2/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.5%
2/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
12.3%
8/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Viral upper respiratory tract infection
13.3%
2/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Gastroenteritis
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Lower respiratory tract infection
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Molluscum contagiosum
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Otitis media
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Respiratory tract infection
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Skin infection
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Tonsillitis
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Viral pharyngitis
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Herpes simplex
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Lobar pneumonia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Nail infection
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Otitis externa
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Pharyngitis streptococcal
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.6%
3/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Pharyngotonsillitis
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Tonsillitis bacterial
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Urinary tract infections
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Viral infection
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Influenza
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.6%
3/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Rhinitis
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Vulvovaginal mycotic infection
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.6%
3/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Ear infection
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Pharyngitis
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Sinusitis
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Candida infection
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Gastroenteritis viral
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Gastrointestinal pain
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Herpes zoster
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Oral herpes
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Pneumonia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Nervous system disorders
Headache
53.3%
8/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
42.9%
9/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
29.5%
13/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
43.1%
28/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Nervous system disorders
Paraesthesia
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Nervous system disorders
Dizziness
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.5%
2/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
7.7%
5/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Nervous system disorders
Hypersomnia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Nervous system disorders
Migraine
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Nervous system disorders
Sinus headache
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Respiratory, thoracic and mediastinal disorders
Epistaxis
20.0%
3/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
14.3%
3/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
16.9%
11/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Respiratory, thoracic and mediastinal disorders
Cough
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
6.8%
3/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
13.8%
9/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
11.4%
5/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
13.8%
9/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Respiratory, thoracic and mediastinal disorders
Sneezing
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.5%
2/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.6%
3/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Respiratory, thoracic and mediastinal disorders
Nasal congestion
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
7.7%
5/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Respiratory, thoracic and mediastinal disorders
Bronchospasm
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Respiratory, thoracic and mediastinal disorders
Dyspnoea
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Respiratory, thoracic and mediastinal disorders
Nasal discharge discolouration
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Respiratory, thoracic and mediastinal disorders
Wheezing
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Animal bite
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Fall
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Injury
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Laceration
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Concussion
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Infections and infestations
Contusion
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Incision site pruritus
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Periorbital contusion
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Tooth fracture
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Wound haemorrhage
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Excoriation
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
9.5%
2/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Joint injury
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Limb injury
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Wrist fracture
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Head injury
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Ligament sprain
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Post procedural haemorrhage
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Injury, poisoning and procedural complications
Upper limb fracture
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Acne
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Pruritus
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Rash
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.5%
2/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
7.7%
5/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Petechiae
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.5%
2/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.6%
3/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Blister
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Eczema
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.6%
3/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Erythema multiforme
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Rash papular
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Skin haemorrhage
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Rash pruritic
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.6%
3/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Urticaria
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Alopecia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Dermatitis allergic
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Dry skin
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Erythema
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Pityriasis rosea
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Rash macular
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Skin and subcutaneous tissue disorders
Swelling face
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
Blood glucose decreased
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
Weight increased
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
White blood cell count decreased
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
Activated partial thromboplastin time prolonged
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
Blood creatinine increased
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
Blood urea increased
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
Alanine aminotransferase increased
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
Blood albumin decreased
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
Blood fibrinogen decreased
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
Haemoglobin decreased
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
Neutrophil count decreased
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
Prothrombin time prolonged
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
Transaminases increased
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Investigations
Weight decreased
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Reproductive system and breast disorders
Dysmenorrhoea
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.5%
2/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
6.2%
4/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Reproductive system and breast disorders
Menorrhagia
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Reproductive system and breast disorders
Metrorrhagia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Reproductive system and breast disorders
Uterine pain
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Reproductive system and breast disorders
Vulvovaginal erythema
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Reproductive system and breast disorders
Vulvovaginal pruritus
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Eye disorders
Astigmatism
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Eye disorders
Eyelid oedema
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Eye disorders
Ocular hyperaemia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Eye disorders
Conjunctivitis
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.6%
3/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Eye disorders
Vision blurred
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
General disorders
Asthenia
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
General disorders
Pyrexia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
14.3%
3/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
13.6%
6/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
23.1%
15/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
General disorders
Fatigue
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
9.5%
2/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
6.8%
3/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
12.3%
8/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
General disorders
Malaise
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
General disorders
Mucosal haemorrhage
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
General disorders
Pain
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
General disorders
Adverse drug reaction
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
General disorders
Influenza like illness
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
General disorders
Local swelling
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
General disorders
Feeling jittery
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Musculoskeletal and connective tissue disorders
Pain in extremity
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
9.5%
2/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
9.2%
6/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Musculoskeletal and connective tissue disorders
Arthralgia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
9.5%
2/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.5%
2/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
9.2%
6/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Musculoskeletal and connective tissue disorders
Back pain
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Musculoskeletal and connective tissue disorders
Neck pain
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Musculoskeletal and connective tissue disorders
Pain in jaw
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Musculoskeletal and connective tissue disorders
Joint effusion
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Musculoskeletal and connective tissue disorders
Muscular weakness
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Musculoskeletal and connective tissue disorders
Myalgia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Psychiatric disorders
Middle insomnia
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Psychiatric disorders
Agitation
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Psychiatric disorders
Anxiety
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Psychiatric disorders
Initial insomnia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Psychiatric disorders
Nightmare
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Psychiatric disorders
Tic
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Psychiatric disorders
Insomnia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.6%
3/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Psychiatric disorders
Restlessness
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Ear and labyrinth disorders
Ear pain
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.5%
2/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
7.7%
5/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Ear and labyrinth disorders
Tympanic membrane perforation
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Ear and labyrinth disorders
Haematotympanum
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Ear and labyrinth disorders
Otorrhoea
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Blood and lymphatic system disorders
Leukopenia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.5%
2/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.6%
3/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Blood and lymphatic system disorders
Lymphopenia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Blood and lymphatic system disorders
Neutropenia
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.6%
3/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Blood and lymphatic system disorders
Thrombocytosis
6.7%
1/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Blood and lymphatic system disorders
Thrombocytopenia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Blood and lymphatic system disorders
Anaemia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Blood and lymphatic system disorders
Coagulopathy
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Blood and lymphatic system disorders
Granulocytopenia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Blood and lymphatic system disorders
Haemolytic anaemia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Blood and lymphatic system disorders
Iron deficiency anaemia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Blood and lymphatic system disorders
Lymphadenopathy
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Metabolism and nutrition disorders
Dehydration
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Metabolism and nutrition disorders
Hypoalbuminaemia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Metabolism and nutrition disorders
Iron deficiency
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Metabolism and nutrition disorders
Hyperglycaemia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Metabolism and nutrition disorders
Hyperkalaemia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Metabolism and nutrition disorders
Hypokalaemia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Renal and urinary disorders
Dysuria
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Renal and urinary disorders
Enuresis
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Renal and urinary disorders
Decreased appetite
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Renal and urinary disorders
Proteinuria
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Vascular disorders
Hypertension
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
2.3%
1/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Vascular disorders
Flushing
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Vascular disorders
Haematoma
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Vascular disorders
Hot flush
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Hepatobiliary disorders
Hyperbilirubinaemia
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Immune system disorders
Seasonal allergy
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
4.8%
1/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
6.2%
4/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Immune system disorders
Drug hypersensitivity
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
3.1%
2/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
Immune system disorders
Hypersensitivity
0.00%
0/15 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/21 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
0.00%
0/44 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.
1.5%
1/65 • On-treatment adverse events (AEs) and serious adverse events (SAEs) are defined as events occuring from the start of the investigational product until the end of treatment (up to Study Week 31)
SAEs and non-serious AEs were collected in members of the Safety Population, comprised of all participants who had received at least one dose of the investigational product.

Additional Information

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Phone: 866-435-7343

Results disclosure agreements

  • Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
  • Publication restrictions are in place

Restriction type: OTHER