Trial Outcomes & Findings for Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE) (NCT NCT03134222)
NCT ID: NCT03134222
Last Updated: 2020-06-09
Results Overview
CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
47 participants
Primary outcome timeframe
Baseline; Week 12
Results posted on
2020-06-09
Participant Flow
Participants were enrolled at study sites in the United States and Canada. The first participant was screened on 24 May 2017. The last study visit occurred on 18 December 2019.
72 participants were screened.
Participant milestones
| Measure |
Lanraplenib 30 mg
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
|
Filgotinib 200 mg
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
|
Placebo
Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
|
Placebo to Lanraplenib 30 mg
After Week 12 Visit, participants on placebo were rerandomized 1:1 and received lanraplenib 30 mg + filgotinib placebo once daily in a blinded fashion through Week 48.
|
Placebo to Filgotinib 200 mg
After Week 12 Visit, participants on placebo were rerandomized 1:1 and received filgotinib 200 mg + lanraplenib placebo once daily in a blinded fashion through Week 48.
|
|---|---|---|---|---|---|
|
Treatment Period (Up to Week 12)
STARTED
|
19
|
18
|
10
|
0
|
0
|
|
Treatment Period (Up to Week 12)
COMPLETED
|
14
|
14
|
8
|
0
|
0
|
|
Treatment Period (Up to Week 12)
NOT COMPLETED
|
5
|
4
|
2
|
0
|
0
|
|
Treatment Period (Week 12 to 48)
STARTED
|
14
|
14
|
0
|
4
|
4
|
|
Treatment Period (Week 12 to 48)
COMPLETED
|
12
|
11
|
0
|
3
|
3
|
|
Treatment Period (Week 12 to 48)
NOT COMPLETED
|
2
|
3
|
0
|
1
|
1
|
Reasons for withdrawal
| Measure |
Lanraplenib 30 mg
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
|
Filgotinib 200 mg
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
|
Placebo
Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
|
Placebo to Lanraplenib 30 mg
After Week 12 Visit, participants on placebo were rerandomized 1:1 and received lanraplenib 30 mg + filgotinib placebo once daily in a blinded fashion through Week 48.
|
Placebo to Filgotinib 200 mg
After Week 12 Visit, participants on placebo were rerandomized 1:1 and received filgotinib 200 mg + lanraplenib placebo once daily in a blinded fashion through Week 48.
|
|---|---|---|---|---|---|
|
Treatment Period (Up to Week 12)
Adverse Event
|
4
|
1
|
0
|
0
|
0
|
|
Treatment Period (Up to Week 12)
Lost to Follow-up
|
1
|
1
|
1
|
0
|
0
|
|
Treatment Period (Up to Week 12)
Withdrew Consent
|
0
|
1
|
0
|
0
|
0
|
|
Treatment Period (Up to Week 12)
Randomized but not treated
|
0
|
1
|
1
|
0
|
0
|
|
Treatment Period (Week 12 to 48)
Withdrew Consent
|
0
|
2
|
0
|
0
|
1
|
|
Treatment Period (Week 12 to 48)
Lack of Efficacy
|
2
|
0
|
0
|
0
|
0
|
|
Treatment Period (Week 12 to 48)
Investigator's Discretion
|
0
|
0
|
0
|
1
|
0
|
|
Treatment Period (Week 12 to 48)
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Study to Evaluate Safety and Efficacy of Filgotinib and Lanraplenib in Females With Moderately-to-Severely Active Cutaneous Lupus Erythematosus (CLE)
Baseline characteristics by cohort
| Measure |
Lanraplenib 30 mg
n=19 Participants
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
|
Filgotinib 200 mg
n=17 Participants
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
|
Placebo
n=9 Participants
Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks. After Week 12 Visit, participants were rerandomized 1:1 and received filgotinib 200 mg + lanraplenib placebo or lanraplenib 30 mg + filgotinib placebo once daily in a blinded fashion through Week 48.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
51 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
43 years
STANDARD_DEVIATION 11.5 • n=7 Participants
|
46 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
47 years
STANDARD_DEVIATION 10.1 • n=4 Participants
|
|
Sex: Female, Male
Female
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
45 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
25 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
8 participants
n=4 Participants
|
|
Region of Enrollment
United States
|
15 participants
n=5 Participants
|
16 participants
n=7 Participants
|
6 participants
n=5 Participants
|
37 participants
n=4 Participants
|
|
Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score
|
17.1 score on a scale
STANDARD_DEVIATION 6.11 • n=5 Participants
|
19.7 score on a scale
STANDARD_DEVIATION 14.35 • n=7 Participants
|
14.8 score on a scale
STANDARD_DEVIATION 4.79 • n=5 Participants
|
17.6 score on a scale
STANDARD_DEVIATION 9.89 • n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 12Population: Treatment policy-estimand is the primary estimand for the primary endpoint analysis which involved participants in the Full Analysis Set (who were randomized and received at least one dose of study drug \[filgotinib, lanraplenib or placebo\]) with available data.
CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.
Outcome measures
| Measure |
Lanraplenib 30 mg
n=16 Participants
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
|
Filgotinib 200 mg
n=16 Participants
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
|
Placebo
n=8 Participants
Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
|
|---|---|---|---|
|
Change in Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) Activity Score From Baseline to Week 12
|
-4.5 score on a scale
Standard Error 1.91
|
-8.7 score on a scale
Standard Error 1.85
|
-5.5 score on a scale
Standard Error 2.56
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set were analyzed. Missing data are imputed as No Response.
CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.
Outcome measures
| Measure |
Lanraplenib 30 mg
n=19 Participants
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
|
Filgotinib 200 mg
n=17 Participants
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
|
Placebo
n=9 Participants
Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants at Week 12 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline
|
47.4 Percentage of participants
Interval 24.4 to 71.1
|
64.7 Percentage of participants
Interval 38.3 to 85.8
|
44.4 Percentage of participants
Interval 13.7 to 78.8
|
SECONDARY outcome
Timeframe: Baseline; Week 12Population: Participants in the Full Analysis Set were analyzed. Missing data are imputed as No Response.
CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.
Outcome measures
| Measure |
Lanraplenib 30 mg
n=19 Participants
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
|
Filgotinib 200 mg
n=17 Participants
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
|
Placebo
n=9 Participants
Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants at Week 12 With No Worsening in CLASI Activity Score From Baseline
|
84.2 Percentage of participants
Interval 60.4 to 96.6
|
94.1 Percentage of participants
Interval 71.3 to 99.9
|
88.9 Percentage of participants
Interval 51.8 to 99.7
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set who were randomized to Filgotinib 200 mg or Lanraplenib 200 mg.
CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease.
Outcome measures
| Measure |
Lanraplenib 30 mg
n=14 Participants
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
|
Filgotinib 200 mg
n=12 Participants
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
|
Placebo
Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants at Week 24 With Decrease of ≥ 5 Points in CLASI Activity Score From Baseline
|
50.0 Percentage of participants
Interval 23.0 to 77.0
|
83.3 Percentage of participants
Interval 51.6 to 97.9
|
—
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set who were randomized to Filgotinib 200 mg or Lanraplenib 200 mg.
CLASI Activity is scored based on erythema, scale/hyperkeratosis, mucous membrane involvement, acute hair loss and nonscarring alopecia. Evaluation of erythema and scale/hyperkeratosis is based on a table: rows represent anatomical areas and columns represent major clinical symptoms. The extent of involvement for each of the skin symptoms is documented for each anatomic area. The total score ranges from 0-70, with higher scores indicating more severe skin disease. Worsening was defined as ≥ 3 point increase in CLASI activity score.
Outcome measures
| Measure |
Lanraplenib 30 mg
n=14 Participants
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
|
Filgotinib 200 mg
n=12 Participants
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
|
Placebo
Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
|
|---|---|---|---|
|
Percentage of Participants at Week 24 With No Worsening in CLASI Activity Score From Baseline
|
85.7 Percentage of participants
Interval 57.2 to 98.2
|
100.0 Percentage of participants
Interval 73.5 to 100.0
|
—
|
Adverse Events
Lanraplenib 30 mg
Serious events: 2 serious events
Other events: 17 other events
Deaths: 0 deaths
Filgotinib 200 mg
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo to Lanraplenib 30 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo to Filgotinib 200 mg
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lanraplenib 30 mg
n=19 participants at risk
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
|
Filgotinib 200 mg
n=17 participants at risk
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
|
Placebo
n=9 participants at risk
Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
|
Placebo to Lanraplenib 30 mg
n=4 participants at risk
After Week 12 Visit, participants on placebo were rerandomized 1:1 and received lanraplenib 30 mg + filgotinib placebo once daily in a blinded fashion through Week 48.
|
Placebo to Filgotinib 200 mg
n=4 participants at risk
After Week 12 Visit, participants on placebo were rerandomized 1:1 and received filgotinib 200 mg + lanraplenib placebo once daily in a blinded fashion through Week 48.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Coronary artery occlusion
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Lanraplenib 30 mg
n=19 participants at risk
Lanraplenib 30 mg + filgotinib placebo tablets orally once daily for 48 weeks
|
Filgotinib 200 mg
n=17 participants at risk
Filgotinib 200 mg + lanraplenib placebo tablets orally once daily for 48 weeks
|
Placebo
n=9 participants at risk
Participants received filgotinib placebo + lanraplenib placebo tablets orally once daily for 12 weeks.
|
Placebo to Lanraplenib 30 mg
n=4 participants at risk
After Week 12 Visit, participants on placebo were rerandomized 1:1 and received lanraplenib 30 mg + filgotinib placebo once daily in a blinded fashion through Week 48.
|
Placebo to Filgotinib 200 mg
n=4 participants at risk
After Week 12 Visit, participants on placebo were rerandomized 1:1 and received filgotinib 200 mg + lanraplenib placebo once daily in a blinded fashion through Week 48.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
1/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
1/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
10.5%
2/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
1/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
10.5%
2/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
17.6%
3/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.8%
2/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.1%
1/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.8%
2/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Immune system disorders
Seasonal allergy
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Acne pustular
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Bronchitis
|
10.5%
2/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Cystitis
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
1/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis viral
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
1/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral herpes
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Otitis externa
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Postoperative wound infection
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.8%
2/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 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
|
21.1%
4/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
17.6%
3/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
22.2%
2/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
15.8%
3/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.8%
2/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 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%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.1%
1/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.8%
2/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foreign body
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
1/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Hepatic enzyme increased
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Liver function test increased
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Vitamin D decreased
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Weight increased
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.1%
1/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 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%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 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
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.8%
2/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 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%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.1%
1/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 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
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
1/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 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
|
10.5%
2/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 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)
Skin papilloma
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.1%
1/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
10.5%
2/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
23.5%
4/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
1/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.1%
1/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Uterine mass
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.1%
1/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.1%
1/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.8%
2/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus pain
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
11.1%
1/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 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%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
1/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Tooth extraction
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
5.9%
1/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Vascular disorders
Haematoma
|
5.3%
1/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/19 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/17 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/9 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/4 • First dose date up to Week 48 plus 30 days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
1/4 • First dose date up to Week 48 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