Trial Outcomes & Findings for A Study of LY2228820 in Participants With Advanced Cancer (NCT NCT01393990)
NCT ID: NCT01393990
Last Updated: 2020-03-24
Results Overview
Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after the administration of at least 1 dose of study drug, regardless of causality. A summary of serious AEs (SAEs) and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
89 participants
Primary outcome timeframe
Baseline to study completion (Up to 41 months)
Results posted on
2020-03-24
Participant Flow
The study had 4 parts, dose-escalation (Part A), 2 dose-confirmation (Parts B and C), and a tumor-specific expansion for metastatic breast cancer (Part D). Completers for Parts A and D were defined as any participant who completed Cycle 2 or had a dose-limiting toxicology (DLT) in Cycle 1 and did not enter Cycle 2.
Participant milestones
| Measure |
Part A: 10 mg LY2228820 Capsules
10 milligrams (mg) LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 20 mg LY2228820 Capsules
20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 40 mg LY2228820 Capsules
40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 65 mg LY2228820 Capsules
65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 90 mg LY2228820 Capsules
90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 120 mg LY2228820 Capsules
120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Capsules
160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Capsules
200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg Bridge LY2228820
In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
|
Part A: 160 mg LY2228820 Tablets
160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Tablets
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 420 mg LY2228820 Tablets
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 560 mg LY2228820 Tablets
560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part B: 420 mg LY2228820 Tablets
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
|
Part C: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
|
Part D: 200 mg LY2228820 Tablets
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
Part D: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
3
|
5
|
3
|
3
|
7
|
6
|
3
|
3
|
3
|
3
|
5
|
18
|
8
|
3
|
6
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
4
|
3
|
3
|
3
|
5
|
3
|
3
|
7
|
6
|
3
|
3
|
3
|
3
|
5
|
18
|
8
|
3
|
6
|
|
Overall Study
COMPLETED
|
3
|
3
|
3
|
2
|
3
|
2
|
2
|
6
|
3
|
2
|
3
|
3
|
3
|
3
|
9
|
5
|
3
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
2
|
1
|
1
|
1
|
3
|
1
|
0
|
0
|
0
|
2
|
9
|
3
|
0
|
0
|
Reasons for withdrawal
| Measure |
Part A: 10 mg LY2228820 Capsules
10 milligrams (mg) LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 20 mg LY2228820 Capsules
20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 40 mg LY2228820 Capsules
40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 65 mg LY2228820 Capsules
65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 90 mg LY2228820 Capsules
90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 120 mg LY2228820 Capsules
120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Capsules
160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Capsules
200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg Bridge LY2228820
In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
|
Part A: 160 mg LY2228820 Tablets
160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Tablets
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 420 mg LY2228820 Tablets
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 560 mg LY2228820 Tablets
560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part B: 420 mg LY2228820 Tablets
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
|
Part C: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
|
Part D: 200 mg LY2228820 Tablets
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
Part D: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
|
Overall Study
Progressive Disease
|
1
|
0
|
0
|
1
|
1
|
1
|
1
|
1
|
3
|
1
|
0
|
0
|
0
|
1
|
6
|
1
|
0
|
0
|
|
Overall Study
Death
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
1
|
0
|
0
|
Baseline Characteristics
A Study of LY2228820 in Participants With Advanced Cancer
Baseline characteristics by cohort
| Measure |
Part A: 10 mg LY2228820 Capsules
n=4 Participants
10 milligrams (mg) LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 20 mg LY2228820 Capsules
n=3 Participants
20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 40 mg LY2228820 Capsules
n=3 Participants
40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 65 mg LY2228820 Capsules
n=3 Participants
65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 90 mg LY2228820 Capsules
n=5 Participants
90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 120 mg LY2228820 Capsules
n=3 Participants
120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Capsules
n=3 Participants
160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Capsules
n=7 Participants
200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg Bridge LY2228820
n=6 Participants
In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
|
Part A: 160 mg LY2228820 Tablets
n=3 Participants
160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Tablets
n=3 Participants
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 300 mg LY2228820 Tablets
n=3 Participants
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 420 mg LY2228820 Tablets
n=3 Participants
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 560 mg LY2228820 Tablets
n=5 Participants
560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part B: 420 mg LY2228820 Tablets
n=18 Participants
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
|
Part C: 300 mg LY2228820 Tablets
n=8 Participants
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
|
Part D: 200 mg LY2228820 Tablets
n=3 Participants
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
Part D: 300 mg LY2228820 Tablets
n=6 Participants
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
Total
n=89 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
60.5 years
STANDARD_DEVIATION 11.82 • n=5 Participants
|
60.9 years
STANDARD_DEVIATION 2.09 • n=7 Participants
|
63.8 years
STANDARD_DEVIATION 2.63 • n=5 Participants
|
61.3 years
STANDARD_DEVIATION 9.66 • n=4 Participants
|
64.5 years
STANDARD_DEVIATION 11.13 • n=21 Participants
|
66.0 years
STANDARD_DEVIATION 13.58 • n=10 Participants
|
61.5 years
STANDARD_DEVIATION 1.98 • n=115 Participants
|
64.9 years
STANDARD_DEVIATION 11.90 • n=6 Participants
|
61.5 years
STANDARD_DEVIATION 10.80 • n=6 Participants
|
64.4 years
STANDARD_DEVIATION 4.54 • n=64 Participants
|
49.6 years
STANDARD_DEVIATION 16.79 • n=17 Participants
|
51.1 years
STANDARD_DEVIATION 15.50 • n=21 Participants
|
56.2 years
STANDARD_DEVIATION 17.60 • n=22 Participants
|
70.6 years
STANDARD_DEVIATION 8.33 • n=8 Participants
|
61.1 years
STANDARD_DEVIATION 10.42 • n=16 Participants
|
58.3 years
STANDARD_DEVIATION 8.49 • n=135 Participants
|
56.4 years
STANDARD_DEVIATION 1.15 • n=136 Participants
|
62.5 years
STANDARD_DEVIATION 4.64 • n=44 Participants
|
61.3 years
STANDARD_DEVIATION 10.13 • n=667 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
5 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
1 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
1 Participants
n=8 Participants
|
12 Participants
n=16 Participants
|
4 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
52 Participants
n=667 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
3 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
4 Participants
n=8 Participants
|
6 Participants
n=16 Participants
|
4 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
37 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
African
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
1 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=22 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
0 Participants
n=44 Participants
|
3 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
6 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
2 Participants
n=17 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=22 Participants
|
4 Participants
n=8 Participants
|
18 Participants
n=16 Participants
|
8 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
5 Participants
n=44 Participants
|
82 Participants
n=667 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=64 Participants
|
0 Participants
n=17 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=22 Participants
|
1 Participants
n=8 Participants
|
0 Participants
n=16 Participants
|
0 Participants
n=135 Participants
|
0 Participants
n=136 Participants
|
1 Participants
n=44 Participants
|
4 Participants
n=667 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
7 Participants
n=6 Participants
|
6 Participants
n=6 Participants
|
3 Participants
n=64 Participants
|
3 Participants
n=17 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=22 Participants
|
5 Participants
n=8 Participants
|
18 Participants
n=16 Participants
|
8 Participants
n=135 Participants
|
3 Participants
n=136 Participants
|
6 Participants
n=44 Participants
|
89 Participants
n=667 Participants
|
PRIMARY outcome
Timeframe: Baseline to study completion (Up to 41 months)Population: Any participant who received at least 1 dose of study drug.
Data presented are the number of participants who experienced at least one treatment emergent adverse event (TEAE). A TEAE is defined as an event that first occurred or worsened after the administration of at least 1 dose of study drug, regardless of causality. A summary of serious AEs (SAEs) and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
Outcome measures
| Measure |
Part A: 560 mg LY2228820 Tablets
n=5 Participants
560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part B: 420 mg LY2228820 Tablets
n=18 Participants
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
|
Part A: 10 mg LY2228820 Capsules
n=4 Participants
10 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 20 mg LY2228820 Capsules
n=3 Participants
20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 40 mg LY2228820 Capsules
n=3 Participants
40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 65 mg LY2228820 Capsules
n=3 Participants
65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 90 mg LY2228820 Capsules
n=5 Participants
90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 120 mg LY2228820 Capsules
n=3 Participants
120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Capsules
n=3 Participants
160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Capsules
n=7 Participants
200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Bridge
n=6 Participants
In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
|
Part A: 160 mg LY2228820 Tablets
n=3 Participants
160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Tablets
n=3 Participants
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 300 mg LY2228820 Tablets
n=3 Participants
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 420 mg LY2228820 Tablets
n=3 Participants
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part C: 300 mg LY2228820 Tablets
n=8 Participants
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
|
Part D: 200 mg LY2228820 Tablets
n=3 Participants
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
Part D: 300 mg LY2228820 Tablets
n=6 Participants
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Clinically Significant Effects (Physical Assessments and Safety Lab Tests)
|
4 Participants
|
18 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Baseline to study completion (Up to 41 months)Population: Any participant who received at least 1 dose of study drug.
Recommended Phase 2 dose was determined by maximum tolerated dose (MTD), which was determined by Dose-limiting toxicity (DLT). For the purpose of this study, the MTD was defined as the highest dose level at which no more than 33% of participants experience a DLT during Cycle 1.
Outcome measures
| Measure |
Part A: 560 mg LY2228820 Tablets
560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part B: 420 mg LY2228820 Tablets
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
|
Part A: 10 mg LY2228820 Capsules
n=89 Participants
10 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 20 mg LY2228820 Capsules
20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 40 mg LY2228820 Capsules
40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 65 mg LY2228820 Capsules
65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 90 mg LY2228820 Capsules
90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 120 mg LY2228820 Capsules
120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Capsules
160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Capsules
200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Bridge
In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
|
Part A: 160 mg LY2228820 Tablets
160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Tablets
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 420 mg LY2228820 Tablets
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part C: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
|
Part D: 200 mg LY2228820 Tablets
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
Part D: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Recommended Dose for Phase 2 Studies
|
—
|
—
|
300 milligrams (mg)
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to study completion (Up to 41 months)Population: All participants who received at least 1 dose of study drug.
Response was defined using Response Evaluation Criteria In Solid Tumors (RECIST, version 1.1) criteria. CR was defined as the disappearance of all target and non-target lesions and normalization of tumor marker level in non-target lesions. PR was defined as having at least a 30% decrease in sum of longest diameter (LD) of target lesions. PD was defined as having at least a 20% increase in the sum of the LD of target lesion and appearance of ≥1 new lesion and/or unequivocal progression of existing nontarget lesions. SD was defined as small changes that did not meet the above criteria taking as reference the smallest sum LD since treatment started.
Outcome measures
| Measure |
Part A: 560 mg LY2228820 Tablets
n=5 Participants
560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part B: 420 mg LY2228820 Tablets
n=18 Participants
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
|
Part A: 10 mg LY2228820 Capsules
n=4 Participants
10 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 20 mg LY2228820 Capsules
n=3 Participants
20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 40 mg LY2228820 Capsules
n=3 Participants
40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 65 mg LY2228820 Capsules
n=3 Participants
65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 90 mg LY2228820 Capsules
n=5 Participants
90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 120 mg LY2228820 Capsules
n=3 Participants
120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Capsules
n=3 Participants
160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Capsules
n=7 Participants
200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Bridge
n=6 Participants
In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
|
Part A: 160 mg LY2228820 Tablets
n=3 Participants
160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Tablets
n=3 Participants
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 300 mg LY2228820 Tablets
n=3 Participants
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 420 mg LY2228820 Tablets
n=3 Participants
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part C: 300 mg LY2228820 Tablets
n=8 Participants
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
|
Part D: 200 mg LY2228820 Tablets
n=3 Participants
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
Part D: 300 mg LY2228820 Tablets
n=6 Participants
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Percentage of Participants With Best Overall Response [Complete Response (CR)+Partial Response (PR)+Stable Disease (SD)]
|
0.0 percentage of participants
|
16.7 percentage of participants
|
25.0 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
40.0 percentage of participants
|
33.3 percentage of participants
|
66.7 percentage of participants
|
28.6 percentage of participants
|
16.7 percentage of participants
|
33.3 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
16.7 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1, Days 1 and 14: predose, 0.5, 1, 2, 3, 4, 6 and 8 h postdosePopulation: All participants who received at least 1 dose of study drug and had evaluable PK data. Participants in 300 mg and 420 mg are combined to measure PK outcome; as dose, formulations and population are same.
Outcome measures
| Measure |
Part A: 560 mg LY2228820 Tablets
n=3 Participants
560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part B: 420 mg LY2228820 Tablets
n=6 Participants
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
|
Part A: 10 mg LY2228820 Capsules
n=4 Participants
10 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 20 mg LY2228820 Capsules
n=3 Participants
20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 40 mg LY2228820 Capsules
n=3 Participants
40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 65 mg LY2228820 Capsules
n=3 Participants
65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 90 mg LY2228820 Capsules
n=5 Participants
90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 120 mg LY2228820 Capsules
n=3 Participants
120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Capsules
n=3 Participants
160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Capsules
n=7 Participants
200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Bridge
n=3 Participants
In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
|
Part A: 160 mg LY2228820 Tablets
n=3 Participants
160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Tablets
n=11 Participants
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 300 mg LY2228820 Tablets
n=21 Participants
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 420 mg LY2228820 Tablets
n=5 Participants
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part C: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
|
Part D: 200 mg LY2228820 Tablets
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
Part D: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Area Under the Concentration-Time Curve From Time Zero to 8 Hours (AUC0-8) of LY2228820
Cycle 1 Day 1
|
2360 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 35
|
4500 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 36
|
55.6 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 36
|
257 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 26
|
375 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 79
|
445 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 83
|
707 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 45
|
1310 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 33
|
2120 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 39
|
2550 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 55
|
1750 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 20
|
1720 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 70
|
3460 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 51
|
5780 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 57
|
8880 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 37
|
—
|
—
|
—
|
|
PK: Area Under the Concentration-Time Curve From Time Zero to 8 Hours (AUC0-8) of LY2228820
Cycle 1 Day 14
|
3810 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 116
|
6910 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 55
|
151 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 83
|
372 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 28
|
1070 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 130
|
1300 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 13
|
827 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 61
|
1960 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 50
|
6000 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 29
|
6220 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 42
|
2810 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 22
|
NA nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation NA
Geometric mean and coefficient of variation (CV) not calculated for 2 participants; individual participants values reported: 2140 and 7090
|
6620 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 85
|
10200 nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation 55
|
NA nanograms*hour/milliliter (ng*hr/mL)
Geometric Coefficient of Variation NA
Geometric mean and CV was not calculated for 1 participant; individual participant data reported: 15200
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1, Days 1 and 14: predose, 0.5, 1, 2, 3, 4, 6 and 8 h postdosePopulation: All participants who received at least 1 dose of study treatment and had evaluable PK data. Participants in 300 mg and 420 mg are combined to measure PK outcome; as dose, formulations and population are same.
Outcome measures
| Measure |
Part A: 560 mg LY2228820 Tablets
n=3 Participants
560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part B: 420 mg LY2228820 Tablets
n=6 Participants
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
|
Part A: 10 mg LY2228820 Capsules
n=4 Participants
10 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 20 mg LY2228820 Capsules
n=3 Participants
20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 40 mg LY2228820 Capsules
n=3 Participants
40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 65 mg LY2228820 Capsules
n=3 Participants
65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 90 mg LY2228820 Capsules
n=5 Participants
90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 120 mg LY2228820 Capsules
n=3 Participants
120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Capsules
n=3 Participants
160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Capsules
n=7 Participants
200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Bridge
n=3 Participants
In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
|
Part A: 160 mg LY2228820 Tablets
n=3 Participants
160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Tablets
n=11 Participants
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 300 mg LY2228820 Tablets
n=21 Participants
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 420 mg LY2228820 Tablets
n=5 Participants
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part C: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
|
Part D: 200 mg LY2228820 Tablets
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
Part D: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
PK: Maximum Plasma Concentration (Cmax) of LY2228820
Cycle 1 Day 1
|
718 ng/mL
Geometric Coefficient of Variation 27
|
1810 ng/mL
Geometric Coefficient of Variation 42
|
14.7 ng/mL
Geometric Coefficient of Variation 75
|
90.1 ng/mL
Geometric Coefficient of Variation 75
|
144 ng/mL
Geometric Coefficient of Variation 83
|
135 ng/mL
Geometric Coefficient of Variation 87
|
202 ng/mL
Geometric Coefficient of Variation 62
|
405 ng/mL
Geometric Coefficient of Variation 68
|
606 ng/mL
Geometric Coefficient of Variation 53
|
673 ng/mL
Geometric Coefficient of Variation 55
|
454 ng/mL
Geometric Coefficient of Variation 18
|
636 ng/mL
Geometric Coefficient of Variation 78
|
1020 ng/mL
Geometric Coefficient of Variation 58
|
1700 ng/mL
Geometric Coefficient of Variation 71
|
2360 ng/mL
Geometric Coefficient of Variation 28
|
—
|
—
|
—
|
|
PK: Maximum Plasma Concentration (Cmax) of LY2228820
Cycle 1 Day 14
|
1030 ng/mL
Geometric Coefficient of Variation 185
|
1700 ng/mL
Geometric Coefficient of Variation 52
|
28.4 ng/mL
Geometric Coefficient of Variation 63
|
81.4 ng/mL
Geometric Coefficient of Variation 63
|
252 ng/mL
Geometric Coefficient of Variation 144
|
415 ng/mL
Geometric Coefficient of Variation 14
|
208 ng/mL
Geometric Coefficient of Variation 74
|
530 ng/mL
Geometric Coefficient of Variation 38
|
1930 ng/mL
Geometric Coefficient of Variation 64
|
1330 ng/mL
Geometric Coefficient of Variation 56
|
574 ng/mL
Geometric Coefficient of Variation 11
|
963 ng/mL
Geometric Coefficient of Variation 82
|
1400 ng/mL
Geometric Coefficient of Variation 81
|
2230 ng/mL
Geometric Coefficient of Variation 53
|
NA ng/mL
Geometric Coefficient of Variation NA
Geometric mean and coefficient of variation (CV) not calculated for 1 participant; individual participant data was reported: 3060
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1: predose, 1, 2, 4, and 6 h postdosePopulation: All participants who received at least 1 dose of study drug and had evaluable PD data. At the dose confirmation of 300 mg, the pMAPKAP-K2 inhibition reached above 50% on Day 1 as maximum inhibition.
The effect of LY2228820 on PD biomarker was measured as MAPK-activated protein kinase -2 (MAPKAP-K2) level which is regulated by p38 MAPK activity. Inhibition of p38 MAPK activity will result in lower levels of MAPKAPK-2.
Outcome measures
| Measure |
Part A: 560 mg LY2228820 Tablets
560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part B: 420 mg LY2228820 Tablets
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
|
Part A: 10 mg LY2228820 Capsules
n=14 Participants
10 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 20 mg LY2228820 Capsules
20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 40 mg LY2228820 Capsules
40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 65 mg LY2228820 Capsules
65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 90 mg LY2228820 Capsules
90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 120 mg LY2228820 Capsules
120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Capsules
160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Capsules
200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Bridge
In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
|
Part A: 160 mg LY2228820 Tablets
160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Tablets
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 420 mg LY2228820 Tablets
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part C: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
|
Part D: 200 mg LY2228820 Tablets
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
Part D: 300 mg LY2228820 Tablets
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacodynamics (PD): Number of Participants With Greater Than 50% Inhibition of p38 Mitogen-Activated Protein Kinase (MAPK) Activity on Day 1
|
—
|
—
|
14 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
Part A: 10 mg LY2228820 Capsules
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 20 mg LY2228820 Capsules
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 40 mg LY2228820 Capsules
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 65 mg LY2228820 Capsules
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 90 mg LY2228820 Capsules
Serious events: 3 serious events
Other events: 2 other events
Deaths: 1 deaths
Part A: 120 mg LY2228820 Capsules
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 160 mg LY2228820 Capsules
Serious events: 2 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: 200 mg LY2228820 Capsules
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A: 160 mg LY2228820 Bridge
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Part A: 160 mg LY2228820 Tablets
Serious events: 3 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 200 mg LY2228820 Tablets
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 300 mg LY2228820 Tablets
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 420 mg LY2228820 Tablets
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part A: 560 mg LY2228820 Tablets
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
Part B: 420 mg LY2228820 Tablets
Serious events: 7 serious events
Other events: 18 other events
Deaths: 1 deaths
Part C: 300 mg LY2228820 Tablets
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Part D: 200 mg LY2228820 Tablets
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Part D: 300 mg LY2228820 Tablets
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: 10 mg LY2228820 Capsules
n=4 participants at risk
10 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 20 mg LY2228820 Capsules
n=3 participants at risk
20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 40 mg LY2228820 Capsules
n=3 participants at risk
40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 65 mg LY2228820 Capsules
n=3 participants at risk
65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 90 mg LY2228820 Capsules
n=5 participants at risk
90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 120 mg LY2228820 Capsules
n=3 participants at risk
120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Capsules
n=3 participants at risk
160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Capsules
n=7 participants at risk
200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Bridge
n=6 participants at risk
In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
|
Part A: 160 mg LY2228820 Tablets
n=3 participants at risk
160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Tablets
n=3 participants at risk
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 300 mg LY2228820 Tablets
n=3 participants at risk
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 420 mg LY2228820 Tablets
n=3 participants at risk
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 560 mg LY2228820 Tablets
n=5 participants at risk
560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part B: 420 mg LY2228820 Tablets
n=18 participants at risk
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
|
Part C: 300 mg LY2228820 Tablets
n=8 participants at risk
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
|
Part D: 200 mg LY2228820 Tablets
n=3 participants at risk
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
Part D: 300 mg LY2228820 Tablets
n=6 participants at risk
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Cyanosis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Endocarditis enterococcal
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Escherichia bacteraemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Infection
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Lobar pneumonia
|
25.0%
1/4 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Exposure during pregnancy
|
0.00%
0/2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
—
0/0 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
—
0/0 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
2/8 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypovolaemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant ascites
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Convulsion
|
25.0%
1/4 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
—
0/0 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
—
0/0 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory arrest
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
11.1%
2/18 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
Other adverse events
| Measure |
Part A: 10 mg LY2228820 Capsules
n=4 participants at risk
10 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 20 mg LY2228820 Capsules
n=3 participants at risk
20 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 40 mg LY2228820 Capsules
n=3 participants at risk
40 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 65 mg LY2228820 Capsules
n=3 participants at risk
65 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 90 mg LY2228820 Capsules
n=5 participants at risk
90 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 120 mg LY2228820 Capsules
n=3 participants at risk
120 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Capsules
n=3 participants at risk
160 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Capsules
n=7 participants at risk
200 mg LY2228820 was administered orally in capsule form every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 160 mg LY2228820 Bridge
n=6 participants at risk
In Cycle 1, participants received a single dose of 160 mg LY2228820 comprising tablets (Day -14) or capsules (Day -7). In Cycle 2 and beyond, participants received capsules or tablets of 160 mg LY2228820 twice a day on Days 1 through 14 of a 28 day cycle.
|
Part A: 160 mg LY2228820 Tablets
n=3 participants at risk
160 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 200 mg LY2228820 Tablets
n=3 participants at risk
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 300 mg LY2228820 Tablets
n=3 participants at risk
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 420 mg LY2228820 Tablets
n=3 participants at risk
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part A: 560 mg LY2228820 Tablets
n=5 participants at risk
560 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants could continue treatment if there was benefit and they did not meet the discontinuation criteria.
|
Part B: 420 mg LY2228820 Tablets
n=18 participants at risk
420 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg oral midazolam 2 days before the first dose of LY2228820 and again after the morning dose of study drug on Day 8 of Cycle 1.
|
Part C: 300 mg LY2228820 Tablets
n=8 participants at risk
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met.
|
Part D: 200 mg LY2228820 Tablets
n=3 participants at risk
200 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
Part D: 300 mg LY2228820 Tablets
n=6 participants at risk
300 mg LY2228820 was administered orally as tablets every 12 hours on Days 1 through 14 of a 28-day cycle for at least 2 cycles if no discontinuation criteria were met. Participants received 20 mg tamoxifen once a day.
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Trismus
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
37.5%
3/8 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Cranial nerve disorder
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
38.9%
7/18 • Number of events 8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
2/8 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Radicular pain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Sinus headache
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Spinal cord compression
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Nervous system disorders
Tremor
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
22.2%
4/18 • Number of events 4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Depression
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Disinhibition
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Dysuria
|
25.0%
1/4 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Urinary incontinence
|
25.0%
1/4 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Genital rash
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Perineal cyst
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
0.00%
0/2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
—
0/0 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
—
0/0 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
1/2 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/12 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
3/18 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
27.8%
5/18 • Number of events 5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
3/18 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
25.0%
1/4 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
22.2%
4/18 • Number of events 4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
3/6 • Number of events 4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
80.0%
4/5 • Number of events 5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
38.9%
7/18 • Number of events 7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
2/8 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
4/6 • Number of events 8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
11.1%
2/18 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Hot flush
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Hypertension
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Vascular disorders
Hypotension
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
11.1%
2/18 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
3/6 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
11.1%
2/18 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
3/6 • Number of events 4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Pulmonary valve incompetence
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Blepharitis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Dry eye
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Eye irritation
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Eye pain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Eye swelling
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Foreign body sensation in eyes
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Periorbital oedema
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Eye disorders
Vision blurred
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
3/18 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
2/8 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
25.0%
1/4 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
28.6%
2/7 • Number of events 4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
6/18 • Number of events 6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
62.5%
5/8 • Number of events 5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
3/6 • Number of events 4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
3/18 • Number of events 4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
11.1%
2/18 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Faecal incontinence
|
25.0%
1/4 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
4/6 • Number of events 4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
6/18 • Number of events 6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
2/8 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
3/6 • Number of events 6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Salivary gland disorder
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
25.0%
1/4 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
100.0%
3/3 • Number of events 4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
3/6 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
27.8%
5/18 • Number of events 5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Asthenia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Chest discomfort
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Chest pain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Chills
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
100.0%
3/3 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
42.9%
3/7 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
4/6 • Number of events 4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
100.0%
3/3 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
6/18 • Number of events 6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
37.5%
3/8 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
83.3%
5/6 • Number of events 6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Feeling jittery
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Oedema
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
General disorders
Thirst
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Cystitis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Ear infection
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Groin abscess
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Tinea infection
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
11.1%
2/18 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
2/8 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase decreased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood creatine phosphokinase increased
|
25.0%
1/4 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood urea increased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Breath sounds abnormal
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Cardiac murmur
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Electrocardiogram t wave abnormal
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Heart rate irregular
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
International normalised ratio increased
|
25.0%
1/4 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Lymphocyte count increased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
Weight decreased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Investigations
White blood cell count increased
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
28.6%
2/7 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
50.0%
3/6 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
40.0%
2/5 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
44.4%
8/18 • Number of events 8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
25.0%
2/8 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
25.0%
1/4 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
66.7%
2/3 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
3/18 • Number of events 4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
11.1%
2/18 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
2/6 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
20.0%
1/5 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
25.0%
1/4 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
12.5%
1/8 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
5.6%
1/18 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
14.3%
1/7 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
16.7%
1/6 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
11.1%
2/18 • Number of events 2 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/4 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/7 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
33.3%
1/3 • Number of events 1 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/5 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/18 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/8 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/3 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
0.00%
0/6 • Up to 41 Months
All participants who received at least 1 dose of study drug. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been adjusted accordingly.
|
Additional Information
Chief Medical Officer
Eli Lilly and Company
Phone: 800-545-5979
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60