Trial Outcomes & Findings for Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis (NCT NCT02943447)
NCT ID: NCT02943447
Last Updated: 2020-09-22
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
71 participants
Primary outcome timeframe
First dose date up to Week 12 + 30 days
Results posted on
2020-09-22
Participant Flow
Participants were enrolled at study sites in United States, Canada, United Kingdom, and Austria. The first participant was screened on 01 December 2016. The last study visit occurred on 4 September 2019.
130 participants were screened.
Participant milestones
| Measure |
Cilofexor 100 mg
Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
Open-Label Extension (OLE) Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks.
|
Cilofexor 30 mg
Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.
OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks.
|
Placebo
Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks.
|
|---|---|---|---|
|
Blinded Study Phase
STARTED
|
28
|
30
|
13
|
|
Blinded Study Phase
COMPLETED
|
23
|
28
|
12
|
|
Blinded Study Phase
NOT COMPLETED
|
5
|
2
|
1
|
|
Open-Label Extension Phase
STARTED
|
23
|
28
|
12
|
|
Open-Label Extension Phase
COMPLETED
|
5
|
3
|
2
|
|
Open-Label Extension Phase
NOT COMPLETED
|
18
|
25
|
10
|
Reasons for withdrawal
| Measure |
Cilofexor 100 mg
Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
Open-Label Extension (OLE) Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks.
|
Cilofexor 30 mg
Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.
OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks.
|
Placebo
Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks.
|
|---|---|---|---|
|
Blinded Study Phase
Withdrew Consent
|
1
|
2
|
1
|
|
Blinded Study Phase
Adverse Event
|
3
|
0
|
0
|
|
Blinded Study Phase
Investigator's discretion
|
1
|
0
|
0
|
|
Open-Label Extension Phase
Study terminated by sponsor
|
10
|
12
|
6
|
|
Open-Label Extension Phase
Adverse Event
|
4
|
7
|
3
|
|
Open-Label Extension Phase
Lack of Efficacy
|
3
|
4
|
0
|
|
Open-Label Extension Phase
Withdrew consent
|
1
|
1
|
1
|
|
Open-Label Extension Phase
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate the Safety, Tolerability, and Efficacy of Cilofexor in Adults With Primary Biliary Cholangitis Without Cirrhosis
Baseline characteristics by cohort
| Measure |
Cilofexor 100 mg
n=28 Participants
Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
Open Label Extension (OLE) Phase: Following Blinded Study Phase, participants willing to enter OLE phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks.
|
Cilofexor 30 mg
n=30 Participants
Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.
OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks.
|
Placebo
n=13 Participants
Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
OLE Phase: Following Blinded Study Phase, participants willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks.
|
Total
n=71 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
54 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
57 years
STANDARD_DEVIATION 6.3 • n=7 Participants
|
58 years
STANDARD_DEVIATION 5.9 • n=5 Participants
|
56 years
STANDARD_DEVIATION 7.9 • n=4 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
66 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Not Permitted
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Hispanic or Latino
|
26 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Ethnicity · Not Permitted
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
9 participants
n=5 Participants
|
9 participants
n=7 Participants
|
3 participants
n=5 Participants
|
21 participants
n=4 Participants
|
|
Region of Enrollment
Austria
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
7 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
16 participants
n=7 Participants
|
7 participants
n=5 Participants
|
35 participants
n=4 Participants
|
|
Region of Enrollment
United Kingdom
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
2 participants
n=5 Participants
|
8 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: First dose date up to Week 12 + 30 daysPopulation: The Safety Analysis Set included all participants who took at least 1 dose of study drug.
Outcome measures
| Measure |
Blinded Study Phase: Cilofexor 100 mg
n=28 Participants
Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
|
Blinded Study Phase: Cilofexor 30 mg
n=30 Participants
Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.
|
Blinded Study Phase: Placebo
n=13 Participants
Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) in the Blinded Study Phase
TEAEs
|
89.3 percentage of participants
|
76.7 percentage of participants
|
84.6 percentage of participants
|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) in the Blinded Study Phase
TESAEs
|
0 percentage of participants
|
3.3 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: First dose date in the OLE phase up to last dose date (Maximum: 97.4 weeks) + 30 daysPopulation: The OLE Analysis Set included all participants who took at least 1 dose of study drug in the OLE Phase.
Outcome measures
| Measure |
Blinded Study Phase: Cilofexor 100 mg
n=23 Participants
Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
|
Blinded Study Phase: Cilofexor 30 mg
n=28 Participants
Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.
|
Blinded Study Phase: Placebo
n=12 Participants
Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Experiencing TEAEs and TESAEs in the Open-Label Extension (OLE) Phase
TEAEs
|
95.7 percentage of participants
|
89.3 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Experiencing TEAEs and TESAEs in the Open-Label Extension (OLE) Phase
TESAEs
|
4.3 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: First dose date up to Week 12 + 30 daysPopulation: Participants in the Safety Analysis Set were analyzed.
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.
Outcome measures
| Measure |
Blinded Study Phase: Cilofexor 100 mg
n=28 Participants
Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
|
Blinded Study Phase: Cilofexor 30 mg
n=30 Participants
Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.
|
Blinded Study Phase: Placebo
n=13 Participants
Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the Blinded Study Phase
Any Graded Laboratory Abnormality
|
85.7 percentage of participants
|
86.7 percentage of participants
|
92.3 percentage of participants
|
|
Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the Blinded Study Phase
Grade 4 or above Laboratory Abnormalities
|
0 percentage of participants
|
3.3 percentage of participants
|
0 percentage of participants
|
PRIMARY outcome
Timeframe: First dose date in the OLE phase up to last dose date (Maximum: 97.4 weeks) + 30 daysPopulation: Participants in the OLE Analysis Set were analyzed.
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. The most severe graded abnormality from all tests was counted for each participant.
Outcome measures
| Measure |
Blinded Study Phase: Cilofexor 100 mg
n=23 Participants
Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
|
Blinded Study Phase: Cilofexor 30 mg
n=28 Participants
Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.
|
Blinded Study Phase: Placebo
n=12 Participants
Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the OLE Phase
Any Graded Laboratory Abnormality
|
91.3 percentage of participants
|
96.4 percentage of participants
|
100.0 percentage of participants
|
|
Percentage of Participants Who Experienced Graded Laboratory Abnormalities in the OLE Phase
Grade 4 or above Laboratory Abnormalities
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
Adverse Events
Blinded Study Phase: Cilofexor 100 mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Blinded Study Phase: Cilofexor 30 mg
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Blinded Study Phase: Placebo
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
OLE Phase: From Cilofexor 100 mg
Serious events: 1 serious events
Other events: 20 other events
Deaths: 0 deaths
OLE Phase: From Cilofexor 30 mg
Serious events: 0 serious events
Other events: 25 other events
Deaths: 0 deaths
OLE Phase: From Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Blinded Study Phase: Cilofexor 100 mg
n=28 participants at risk
Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
|
Blinded Study Phase: Cilofexor 30 mg
n=30 participants at risk
Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.
|
Blinded Study Phase: Placebo
n=13 participants at risk
Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
|
OLE Phase: From Cilofexor 100 mg
n=23 participants at risk
OLE Phase: Following Blinded Study Phase, participants in the Cilofexor 100 mg group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks.
|
OLE Phase: From Cilofexor 30 mg
n=28 participants at risk
OLE Phase: Following Blinded Study Phase, participants in the Cilofexor 30 mg group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks.
|
OLE Phase: From Placebo
n=12 participants at risk
OLE Phase: Following Blinded Study Phase, participants in the Placebo group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks.
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Appendicitis
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.3%
1/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
Other adverse events
| Measure |
Blinded Study Phase: Cilofexor 100 mg
n=28 participants at risk
Blinded Study Phase: Cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
|
Blinded Study Phase: Cilofexor 30 mg
n=30 participants at risk
Blinded Study Phase: Cilofexor 30 mg tablet + placebo to match cilofexor 100 mg tablet orally once daily for 12 weeks.
|
Blinded Study Phase: Placebo
n=13 participants at risk
Blinded Study Phase: Placebo to match cilofexor 100 mg tablet + placebo to match cilofexor 30 mg tablet orally once daily for 12 weeks.
|
OLE Phase: From Cilofexor 100 mg
n=23 participants at risk
OLE Phase: Following Blinded Study Phase, participants in the Cilofexor 100 mg group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.4 weeks.
|
OLE Phase: From Cilofexor 30 mg
n=28 participants at risk
OLE Phase: Following Blinded Study Phase, participants in the Cilofexor 30 mg group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 96.1 weeks.
|
OLE Phase: From Placebo
n=12 participants at risk
OLE Phase: Following Blinded Study Phase, participants in the Placebo group, willing to enter OLE Phase received open-label cilofexor 100 mg tablet orally once daily for 97.3 weeks.
|
|---|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
6.7%
2/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.7%
2/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Eye disorders
Dry eye
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
13.0%
3/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
6.7%
2/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.3%
1/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.6%
1/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
6.7%
2/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
10.7%
3/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.6%
1/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.3%
1/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Gastrointestinal disorders
Barrett's oesophagus
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Gastrointestinal disorders
Constipation
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.3%
1/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
15.4%
2/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.7%
2/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
16.7%
2/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
4/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
13.3%
4/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
21.4%
6/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
33.3%
4/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Gastrointestinal disorders
Dry mouth
|
3.6%
1/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Gastrointestinal disorders
Dyspepsia
|
10.7%
3/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.6%
1/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
16.7%
2/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Gastrointestinal disorders
Nausea
|
10.7%
3/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
6.7%
2/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
23.1%
3/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
13.0%
3/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
16.7%
2/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.3%
1/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.6%
1/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
General disorders
Cyst
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
General disorders
Fatigue
|
17.9%
5/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
6.7%
2/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
23.1%
3/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
13.0%
3/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
14.3%
4/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
16.7%
2/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
General disorders
Influenza like illness
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.7%
2/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
General disorders
Peripheral swelling
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
General disorders
Pyrexia
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.3%
1/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.6%
1/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
General disorders
Suprapubic pain
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Infections and infestations
Abscess neck
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.7%
2/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Infections and infestations
Carbuncle
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Infections and infestations
Influenza
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
16.7%
2/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Infections and infestations
Nasopharyngitis
|
14.3%
4/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
16.7%
5/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
13.0%
3/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
14.3%
4/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.3%
1/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.6%
1/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Infections and infestations
Skin infection
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.3%
1/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.6%
1/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
6.7%
2/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.7%
2/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
16.7%
2/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Injury, poisoning and procedural complications
Procedural anxiety
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.6%
1/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
10.7%
3/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
16.7%
2/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
16.7%
2/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
16.7%
2/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.3%
1/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
13.0%
3/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.6%
1/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.3%
1/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.7%
2/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
10.7%
3/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Nervous system disorders
Headache
|
14.3%
4/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
13.3%
4/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
30.8%
4/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.7%
2/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.6%
1/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.3%
1/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Nervous system disorders
Tension headache
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.7%
2/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.3%
1/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.7%
2/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
46.4%
13/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
20.0%
6/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
23.1%
3/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
17.4%
4/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
39.3%
11/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
50.0%
6/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
14.3%
4/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.6%
1/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.7%
2/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.1%
2/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.6%
1/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
4.3%
1/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
7.7%
1/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Vascular disorders
Flushing
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
|
Vascular disorders
Hypertension
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
3.3%
1/30 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/13 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.7%
2/23 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
0.00%
0/28 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
8.3%
1/12 • Blinded Study Phase: First dose date up to Week 12 + 30 days; Open-label Extension (OLE) Phase: First dose date in the OLE Phase up to last dose date (Maximum: 97.4 weeks) + 30 days
The Safety Analysis Set for Blinded Study phase included all participants who took at least 1 dose of study drug in Blinded Study phase and the OLE Analysis Set included all participants who took at least 1 dose of study drug in OLE phase.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER