Trial Outcomes & Findings for Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome (NCT NCT03100942)
NCT ID: NCT03100942
Last Updated: 2020-10-23
Results Overview
Response was defined as: Improvement ≥ 20% in ≥ 3 of 5 participant-reported Sjogren's syndrome (SjS) related visual analogue score (VAS) measures (participant's assessment of global disease, pain, oral dryness, ocular dryness and fatigue), with no increase defined as \> 30 mm from baseline (Day 1) in any of the above 5 VAS measures, AND either ≥ 20% improvement in high sensitivity C-reactive protein (hsCRP) (if hsCRP ≥ 1.5 x upper limit of normal \[ULN\] on Day 1) or no increase in hsCRP to ≥ 1.5 x ULN (if hsCRP \< 1.5 x ULN on Day 1).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
152 participants
Primary outcome timeframe
Week 12
Results posted on
2020-10-23
Participant Flow
Participants were enrolled at study sites in the United States and Europe. The first participant was screened on 01 May 2017. The last study visit occurred on 02 October 2019.
348 participants were screened.
Participant milestones
| Measure |
Lanraplenib
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 49.4 weeks.
|
Filgotinib
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 50.4 weeks
|
Tirabrutinib
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for up to 50.3 weeks
|
Placebo
Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks.
At Week 24 visit, participants were re-randomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48:
* filgotinib + lanraplenib placebo + tirabrutinib placebo
* lanraplenib + filgotinib placebo + tirabrutinib placebo
* tirabrutinib + filgotinib placebo + lanraplenib placebo
|
Placebo to Lanraplenib
Participants who received placebo for 24 weeks were re-randomized at the Week 24 visit and received lanraplenib (1 × 30 mg tablet) + filgotinib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 25.1 weeks.
|
Placebo to Filgotinib
Participants who received placebo for 24 weeks were re-randomized at the Week 24 visit and received filgotinib (1 × 200 mg tablet) + lanraplenib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 24.4 weeks.
|
Placebo to Tirabrutinib
Participants who received placebo for 24 weeks were re-randomized at the Week 24 visit and received tirabrutinib (1 × 40 mg tablet) + filgotinib placebo (1 × tablet) + lanraplenib placebo (1 × tablet) orally once daily for up to 24.9 weeks.
|
|---|---|---|---|---|---|---|---|
|
Randomized Treatment Period
STARTED
|
38
|
38
|
39
|
37
|
0
|
0
|
0
|
|
Randomized Treatment Period
COMPLETED
|
26
|
29
|
33
|
32
|
0
|
0
|
0
|
|
Randomized Treatment Period
NOT COMPLETED
|
12
|
9
|
6
|
5
|
0
|
0
|
0
|
|
Placebo Arm Re-Randomized
STARTED
|
0
|
0
|
0
|
0
|
10
|
12
|
10
|
|
Placebo Arm Re-Randomized
COMPLETED
|
0
|
0
|
0
|
0
|
10
|
12
|
9
|
|
Placebo Arm Re-Randomized
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Lanraplenib
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 49.4 weeks.
|
Filgotinib
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 50.4 weeks
|
Tirabrutinib
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for up to 50.3 weeks
|
Placebo
Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks.
At Week 24 visit, participants were re-randomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48:
* filgotinib + lanraplenib placebo + tirabrutinib placebo
* lanraplenib + filgotinib placebo + tirabrutinib placebo
* tirabrutinib + filgotinib placebo + lanraplenib placebo
|
Placebo to Lanraplenib
Participants who received placebo for 24 weeks were re-randomized at the Week 24 visit and received lanraplenib (1 × 30 mg tablet) + filgotinib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 25.1 weeks.
|
Placebo to Filgotinib
Participants who received placebo for 24 weeks were re-randomized at the Week 24 visit and received filgotinib (1 × 200 mg tablet) + lanraplenib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 24.4 weeks.
|
Placebo to Tirabrutinib
Participants who received placebo for 24 weeks were re-randomized at the Week 24 visit and received tirabrutinib (1 × 40 mg tablet) + filgotinib placebo (1 × tablet) + lanraplenib placebo (1 × tablet) orally once daily for up to 24.9 weeks.
|
|---|---|---|---|---|---|---|---|
|
Randomized Treatment Period
Withdrew Consent
|
4
|
5
|
3
|
3
|
0
|
0
|
0
|
|
Randomized Treatment Period
Adverse Event
|
5
|
2
|
1
|
0
|
0
|
0
|
0
|
|
Randomized Treatment Period
Investigator's Discretion
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Randomized Treatment Period
Protocol Violation
|
0
|
1
|
1
|
1
|
0
|
0
|
0
|
|
Randomized Treatment Period
Lost to Follow-up
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Randomized Treatment Period
Randomized but Didn't Receive Study Drug
|
1
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Placebo Arm Re-Randomized
Withdrew Consent
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Study to Assess Safety and Efficacy of Filgotinib, Lanraplenib and Tirabrutinib in Adults With Active Sjogren's Syndrome
Baseline characteristics by cohort
| Measure |
Lanraplenib
n=37 Participants
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 49.4 weeks.
|
Filgotinib
n=38 Participants
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 50.4 weeks.
|
Tirabrutinib
n=39 Participants
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for up to 50.3 weeks.
|
Placebo
n=36 Participants
Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks. At Week 24 Visit, participants were rerandomized 1:1:1, in a blinded fashion and received either of the three experimental study drugs orally once daily through Week 48:
* lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
* filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
* tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet)
|
Total
n=150 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
56.2 years
STANDARD_DEVIATION 9.72 • n=5 Participants
|
52.2 years
STANDARD_DEVIATION 10.54 • n=7 Participants
|
55.8 years
STANDARD_DEVIATION 10.06 • n=5 Participants
|
53.2 years
STANDARD_DEVIATION 10.28 • n=4 Participants
|
54.4 years
STANDARD_DEVIATION 10.20 • n=21 Participants
|
|
Sex: Female, Male
Female
|
36 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
146 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
133 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
19 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
White
|
31 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
127 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
26 participants
n=5 Participants
|
27 participants
n=7 Participants
|
30 participants
n=5 Participants
|
23 participants
n=4 Participants
|
106 participants
n=21 Participants
|
|
Region of Enrollment
Poland
|
7 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
22 participants
n=21 Participants
|
|
Region of Enrollment
Spain
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
3 participants
n=5 Participants
|
4 participants
n=4 Participants
|
13 participants
n=21 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
1 participants
n=5 Participants
|
3 participants
n=4 Participants
|
9 participants
n=21 Participants
|
|
European League Against Rheumatism (EULAR) Sjogren's syndrome disease activity index (ESSDAI)
|
10.5 Score on a scale
STANDARD_DEVIATION 4.89 • n=5 Participants
|
10.2 Score on a scale
STANDARD_DEVIATION 6.23 • n=7 Participants
|
10.4 Score on a scale
STANDARD_DEVIATION 5.36 • n=5 Participants
|
9.3 Score on a scale
STANDARD_DEVIATION 3.96 • n=4 Participants
|
10.1 Score on a scale
STANDARD_DEVIATION 5.16 • n=21 Participants
|
|
EULAR Sjogren's syndrome patient reported index (ESSPRI)
|
6.6 Score on a scale
STANDARD_DEVIATION 1.90 • n=5 Participants
|
6.3 Score on a scale
STANDARD_DEVIATION 2.31 • n=7 Participants
|
5.9 Score on a scale
STANDARD_DEVIATION 2.39 • n=5 Participants
|
5.9 Score on a scale
STANDARD_DEVIATION 2.24 • n=4 Participants
|
6.2 Score on a scale
STANDARD_DEVIATION 2.22 • n=21 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: The Full Analysis Set included all randomized participants who received at least one dose of study drug. Included participants with available data.
Response was defined as: Improvement ≥ 20% in ≥ 3 of 5 participant-reported Sjogren's syndrome (SjS) related visual analogue score (VAS) measures (participant's assessment of global disease, pain, oral dryness, ocular dryness and fatigue), with no increase defined as \> 30 mm from baseline (Day 1) in any of the above 5 VAS measures, AND either ≥ 20% improvement in high sensitivity C-reactive protein (hsCRP) (if hsCRP ≥ 1.5 x upper limit of normal \[ULN\] on Day 1) or no increase in hsCRP to ≥ 1.5 x ULN (if hsCRP \< 1.5 x ULN on Day 1).
Outcome measures
| Measure |
Lanraplenib
n=35 Participants
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
|
Filgotinib
n=37 Participants
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
|
Tirabrutinib
n=37 Participants
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for 48 weeks
|
Placebo
n=34 Participants
Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks. At Week 24 Visit, participants were rerandomized 1:1:1, in a blinded fashion and received either of the three experimental study drugs orally once daily through Week 48:
* filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
* lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
* tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet)
|
|---|---|---|---|---|
|
Percentage of Participants Fulfilling Protocol-Specified Response Criteria at Week 12, as Compared to Baseline
|
42.9 percentage of participants
Interval 25.0 to 60.7
|
43.2 percentage of participants
Interval 25.9 to 60.6
|
35.1 percentage of participants
Interval 18.4 to 51.9
|
26.5 percentage of participants
Interval 10.2 to 42.8
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set were analyzed.
The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Outcome measures
| Measure |
Lanraplenib
n=37 Participants
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
|
Filgotinib
n=38 Participants
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
|
Tirabrutinib
n=39 Participants
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for 48 weeks
|
Placebo
n=36 Participants
Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks. At Week 24 Visit, participants were rerandomized 1:1:1, in a blinded fashion and received either of the three experimental study drugs orally once daily through Week 48:
* filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
* lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
* tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet)
|
|---|---|---|---|---|
|
Change From Baseline in European League Against Rheumatism (EULAR) Sjogren's Syndrome Disease Activity Index (ESSDAI) at Week 12
|
-2.5 score on a scale
Standard Error 0.76
|
-4.7 score on a scale
Standard Error 0.72
|
-3.2 score on a scale
Standard Error 0.73
|
-3.9 score on a scale
Standard Error 0.76
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set were analyzed.
The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.
Outcome measures
| Measure |
Lanraplenib
n=37 Participants
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
|
Filgotinib
n=38 Participants
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
|
Tirabrutinib
n=39 Participants
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for 48 weeks
|
Placebo
n=36 Participants
Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks. At Week 24 Visit, participants were rerandomized 1:1:1, in a blinded fashion and received either of the three experimental study drugs orally once daily through Week 48:
* filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
* lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
* tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet)
|
|---|---|---|---|---|
|
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI) at Week 12
|
-1.0 score on a scale
Standard Error 0.34
|
-1.4 score on a scale
Standard Error 0.33
|
-1.4 score on a scale
Standard Error 0.33
|
-1.0 score on a scale
Standard Error 0.34
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set were analyzed.
The ESSDAI is a physician-administered tool designed to measure disease activity. It consists of 12 organ-specific 'domains' contributing to disease activity associated with the participant's Sjogren's Syndrome only (constitutional, lymphadenopathy, articular, muscular, cutaneous, glandular, pulmonary, renal, peripheral nervous system, central nervous system, hematological, biological). Each domain is assessed for activity level (i.e., no, low, moderate, high) and assigned a numerical score based on pre-determined weighting of each individual domain. Overall score (ranges from 0 (no activity) to 123 (worst activity)) is calculated as sum of all individual weighted domain scores. A negative change from baseline value indicates improvement.
Outcome measures
| Measure |
Lanraplenib
n=37 Participants
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
|
Filgotinib
n=38 Participants
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
|
Tirabrutinib
n=39 Participants
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for 48 weeks
|
Placebo
n=36 Participants
Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks. At Week 24 Visit, participants were rerandomized 1:1:1, in a blinded fashion and received either of the three experimental study drugs orally once daily through Week 48:
* filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
* lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
* tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet)
|
|---|---|---|---|---|
|
Change From Baseline in ESSDAI at Week 24
|
-4.3 score on a scale
Standard Error 0.81
|
-5.4 score on a scale
Standard Error 0.75
|
-4.0 score on a scale
Standard Error 0.75
|
-4.2 score on a scale
Standard Error 0.78
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set were analyzed.
The ESSPRI is a participant-reported questionnaire to assess subjective participant symptoms and includes 3 domains (dryness, pain, and fatigue). Each domain is scored on scale of 0-10 (0 = no symptom at all and 10 = worst symptom imaginable), and an overall score is calculated as the mean of the three individual domains where all domains carry the same weight. Minimum score can be 0 and maximum score can be 10. A negative change from baseline value indicates improvement.
Outcome measures
| Measure |
Lanraplenib
n=37 Participants
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
|
Filgotinib
n=38 Participants
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for 48 weeks
|
Tirabrutinib
n=39 Participants
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for 48 weeks
|
Placebo
n=36 Participants
Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks. At Week 24 Visit, participants were rerandomized 1:1:1, in a blinded fashion and received either of the three experimental study drugs orally once daily through Week 48:
* filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
* lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet)
* tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet)
|
|---|---|---|---|---|
|
Change From Baseline in ESSPRI at Week 24
|
-1.1 score on a scale
Standard Error 0.34
|
-0.8 score on a scale
Standard Error 0.31
|
-1.2 score on a scale
Standard Error 0.31
|
-0.9 score on a scale
Standard Error 0.33
|
Adverse Events
Lanraplenib
Serious events: 3 serious events
Other events: 30 other events
Deaths: 0 deaths
Filgotinib
Serious events: 5 serious events
Other events: 31 other events
Deaths: 0 deaths
Tirabrutinib
Serious events: 1 serious events
Other events: 32 other events
Deaths: 0 deaths
Placebo to Lanraplenib
Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo to Filgotinib
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo to Tirabrutinib
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo on Placebo Controlled Period
Serious events: 2 serious events
Other events: 23 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lanraplenib
n=37 participants at risk
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 49.4 weeks.
|
Filgotinib
n=38 participants at risk
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 50.4 weeks.
|
Tirabrutinib
n=39 participants at risk
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for up to 50.3 weeks.
|
Placebo to Lanraplenib
n=10 participants at risk
Participants who received placebo for 24 weeks were rerandomized at the Week 24 visit and received lanraplenib (1 × 30 mg tablet) + filgotinib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 25.1 weeks.
|
Placebo to Filgotinib
n=12 participants at risk
Participants who received placebo for 24 weeks were rerandomized at the Week 24 visit and received filgotinib (1 × 200 mg tablet) + lanraplenib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 24.4 weeks.
|
Placebo to Tirabrutinib
n=10 participants at risk
Participants who received placebo for 24 weeks were rerandomized at the Week 24 visit and received tirabrutinib (1 × 40 mg tablet) + filgotinib placebo (1 × tablet) + lanraplenib placebo (1 × tablet) orally once daily for up to 24.9 weeks.
|
Placebo on Placebo Controlled Period
n=36 participants at risk
Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks in placebo controlled period.
At Week 24 visit, participants were re-randomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48:
* filgotinib + lanraplenib placebo + tirabrutinib placebo
* lanraplenib + filgotinib placebo + tirabrutinib placebo
* tirabrutinib + filgotinib placebo + lanraplenib placeboy once daily for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.8%
1/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.8%
1/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Suicidal ideation
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Lanraplenib
n=37 participants at risk
Lanraplenib (1 x 30 mg tablet) + filgotinib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 49.4 weeks.
|
Filgotinib
n=38 participants at risk
Filgotinib (1 x 200 mg tablet) + lanraplenib placebo (1 x tablet) + tirabrutinib placebo (1 x tablet) orally once daily for up to 50.4 weeks.
|
Tirabrutinib
n=39 participants at risk
Tirabrutinib (1 x 40 mg tablet) + filgotinib placebo (1 x tablet) + lanraplenib placebo (1 x tablet) orally once daily for up to 50.3 weeks.
|
Placebo to Lanraplenib
n=10 participants at risk
Participants who received placebo for 24 weeks were rerandomized at the Week 24 visit and received lanraplenib (1 × 30 mg tablet) + filgotinib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 25.1 weeks.
|
Placebo to Filgotinib
n=12 participants at risk
Participants who received placebo for 24 weeks were rerandomized at the Week 24 visit and received filgotinib (1 × 200 mg tablet) + lanraplenib placebo (1 × tablet) + tirabrutinib placebo (1 × tablet) orally once daily for up to 24.4 weeks.
|
Placebo to Tirabrutinib
n=10 participants at risk
Participants who received placebo for 24 weeks were rerandomized at the Week 24 visit and received tirabrutinib (1 × 40 mg tablet) + filgotinib placebo (1 × tablet) + lanraplenib placebo (1 × tablet) orally once daily for up to 24.9 weeks.
|
Placebo on Placebo Controlled Period
n=36 participants at risk
Participants received filgotinib placebo + lanraplenib placebo + tirabrutinib placebo tablets orally once daily for 24 weeks in placebo controlled period.
At Week 24 visit, participants were re-randomized 1:1:1, in a blinded fashion and receive either of the following study drugs through Week 48:
* filgotinib + lanraplenib placebo + tirabrutinib placebo
* lanraplenib + filgotinib placebo + tirabrutinib placebo
* tirabrutinib + filgotinib placebo + lanraplenib placeboy once daily for 24 weeks.
|
|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.1%
2/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.4%
2/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.4%
2/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Eye disorders
Corneal erosion
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.7%
3/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dental caries
|
5.4%
2/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
8.1%
3/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.9%
3/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.7%
3/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
2/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.8%
1/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.8%
1/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
5.4%
2/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.5%
4/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.1%
2/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.8%
1/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
5.4%
2/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.9%
3/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.1%
2/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
10.8%
4/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.7%
3/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
20.0%
2/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.6%
2/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
8.1%
3/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.8%
1/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.1%
2/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
5.4%
2/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.9%
3/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
3/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis viral
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Furuncle
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
8.1%
3/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.7%
3/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
20.0%
2/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.8%
1/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.7%
3/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Laryngitis
|
5.4%
2/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Lower respiratory tract infection
|
5.4%
2/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
8.1%
3/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
15.8%
6/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.3%
4/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
20.0%
2/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.1%
4/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
5.4%
2/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.9%
3/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Otitis media
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.6%
2/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
5.4%
2/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.8%
5/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
3/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
10.8%
4/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
15.8%
6/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
23.1%
9/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.1%
4/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.3%
4/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
20.0%
2/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
2/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
6/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Vaginal infection
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.1%
2/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.1%
2/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.8%
1/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.1%
2/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
10.8%
4/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.1%
2/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
10.8%
4/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Blood potassium increased
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Light chain analysis increased
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Transaminases increased
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.8%
4/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.5%
4/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
15.4%
6/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Exostosis
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.1%
2/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.4%
2/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.8%
1/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
20.0%
2/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.8%
1/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.9%
3/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Temporomandibular joint syndrome
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
20.0%
2/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
8.1%
3/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
3/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.9%
3/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.7%
3/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.8%
1/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.9%
3/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.1%
2/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.8%
1/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.7%
3/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
3/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.1%
2/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.6%
2/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
5.4%
2/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
10.8%
4/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.3%
2/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.7%
3/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.6%
2/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.1%
2/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.1%
2/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
2.7%
1/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
2.6%
1/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.9%
3/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
7.7%
3/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
8.3%
1/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Vascular disorders
Vasculitis
|
0.00%
0/37 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/38 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/39 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/12 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
10.0%
1/10 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/36 • First dose date up to last dose date (Maximum: 50.4 weeks) plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
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