Trial Outcomes & Findings for Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder (NCT NCT02839200)
NCT ID: NCT02839200
Last Updated: 2020-04-13
Results Overview
WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
360 participants
Primary outcome timeframe
Baseline and Days 1&2
Results posted on
2020-04-13
Participant Flow
Conducted at 38 sites in 6 countries (Germany, Hungary, Israel, Spain, Sweden, and the USA)
Screening details: screening period (screening visit followed by at least 7 days at home) and a run-in period (2 PSG nights on single-blind placebo, followed by 5-12 days with no treatment), and lasting a max. of 28 days. N = 360 subjects were randomized; N = 359 subjects were treated; N = 1 subject discontinued due to "randomization error".
Participant milestones
| Measure |
ACT-541468 5 mg
Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 10 mg
Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 25 mg
Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 50 mg
Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
|
Zolpidem
Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
|
Placebo
Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
60
|
59
|
60
|
61
|
60
|
60
|
|
Overall Study
COMPLETED
|
56
|
58
|
59
|
61
|
58
|
59
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
1
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
ACT-541468 5 mg
Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 10 mg
Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 25 mg
Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 50 mg
Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
|
Zolpidem
Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
|
Placebo
Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
0
|
1
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Randomized in error
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of ACT-541468 in Adult Subjects With Insomnia Disorder
Baseline characteristics by cohort
| Measure |
ACT-541468 5 mg
n=60 Participants
Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 10 mg
n=58 Participants
Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 25 mg
n=60 Participants
Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 50 mg
n=61 Participants
Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
|
Zolpidem
n=60 Participants
Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
|
Placebo
n=60 Participants
Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
Total
n=359 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
41 years
n=5 Participants
|
48 years
n=7 Participants
|
48 years
n=5 Participants
|
46 years
n=4 Participants
|
43 years
n=21 Participants
|
48 years
n=8 Participants
|
47 years
n=8 Participants
|
|
Age, Customized
Adults (18-64 years)
|
60 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
61 Participants
n=4 Participants
|
60 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
359 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
39 Participants
n=4 Participants
|
38 Participants
n=21 Participants
|
38 Participants
n=8 Participants
|
230 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
129 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
9 Participants
n=8 Participants
|
39 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
51 Participants
n=8 Participants
|
319 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
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=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
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=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
35 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
54 Participants
n=5 Participants
|
49 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
54 Participants
n=21 Participants
|
52 Participants
n=8 Participants
|
321 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Baseline and Days 1&2WASO is the time in minutes spent awake after onset of persistent sleep until lights on as determined by polysomnography (PSG)
Outcome measures
| Measure |
ACT-541468 5 mg
n=60 Participants
Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 10 mg
n=58 Participants
Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 25 mg
n=60 Participants
Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 50 mg
n=61 Participants
Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
|
Zolpidem
n=60 Participants
Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
|
Placebo
n=60 Participants
Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
|---|---|---|---|---|---|---|
|
Change in Wake After Sleep Onset (WASO) From Baseline to Days 1 and 2
|
-28.4 minutes
Standard Error 4.24
|
-32.3 minutes
Standard Error 4.32
|
-37.7 minutes
Standard Error 4.25
|
-47.1 minutes
Standard Error 4.21
|
-29.9 minutes
Standard Error 4.30
|
-21.4 minutes
Standard Error 4.24
|
SECONDARY outcome
Timeframe: Baseline and Days 1&2LPS is the duration of time in minutes from lights off to persistent sleep onset as determined by PSG
Outcome measures
| Measure |
ACT-541468 5 mg
n=60 Participants
Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 10 mg
n=58 Participants
Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 25 mg
n=60 Participants
Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 50 mg
n=61 Participants
Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
|
Zolpidem
n=60 Participants
Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
|
Placebo
n=60 Participants
Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
|---|---|---|---|---|---|---|
|
Change in Latency to Persistent Sleep (LPS) From Baseline to Days 1 and 2
|
-26.88 Minutes
Standard Deviation 45.42
|
-29.31 Minutes
Standard Deviation 26.79
|
-36.14 Minutes
Standard Deviation 34.34
|
-36.41 Minutes
Standard Deviation 26.71
|
-45.14 Minutes
Standard Deviation 32.82
|
-22.02 Minutes
Standard Deviation 46.63
|
SECONDARY outcome
Timeframe: Baseline and Week 4sLSO is the self-reported time to fall asleep, as reported in the sleep diary
Outcome measures
| Measure |
ACT-541468 5 mg
n=60 Participants
Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 10 mg
n=58 Participants
Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 25 mg
n=60 Participants
Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 50 mg
n=61 Participants
Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
|
Zolpidem
n=60 Participants
Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
|
Placebo
n=60 Participants
Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
|---|---|---|---|---|---|---|
|
Change in Subjective Latency to Sleep Onset (sLSO) From Baseline to Week 4
|
-13.38 Minutes
Standard Deviation 27.79
|
-21.07 Minutes
Standard Deviation 24.26
|
-15.50 Minutes
Standard Deviation 25.51
|
-23.65 Minutes
Standard Deviation 24.12
|
-19.98 Minutes
Standard Deviation 19.28
|
-16.32 Minutes
Standard Deviation 21.16
|
SECONDARY outcome
Timeframe: Baseline and Week 4sWASO is the self-reported time spent awake after sleep onset as reported in the sleep diary.
Outcome measures
| Measure |
ACT-541468 5 mg
n=51 Participants
Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 10 mg
n=45 Participants
Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 25 mg
n=53 Participants
Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 50 mg
n=49 Participants
Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
|
Zolpidem
n=48 Participants
Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
|
Placebo
n=50 Participants
Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
|---|---|---|---|---|---|---|
|
Change in Subjective Wake After Sleep Onset (sWASO) From Baseline to Week 4
|
-31.32 Minutes
Standard Deviation 33.32
|
-24.35 Minutes
Standard Deviation 33.4
|
-29.8 Minutes
Standard Deviation 39.88
|
-35.45 Minutes
Standard Deviation 37.53
|
-29.08 Minutes
Standard Deviation 27.28
|
-23.61 Minutes
Standard Deviation 32.62
|
Adverse Events
ACT-541468 5 mg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
ACT-541468 10 mg
Serious events: 2 serious events
Other events: 22 other events
Deaths: 0 deaths
ACT-541468 25 mg
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
ACT-541468 50 mg
Serious events: 1 serious events
Other events: 21 other events
Deaths: 0 deaths
Zolpidem
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ACT-541468 5 mg
n=60 participants at risk
Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 10 mg
n=58 participants at risk
Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 25 mg
n=60 participants at risk
Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 50 mg
n=61 participants at risk
Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
|
Zolpidem
n=60 participants at risk
Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
|
Placebo
n=60 participants at risk
Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Injury, poisoning and procedural complications
Accident at work
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
Other adverse events
| Measure |
ACT-541468 5 mg
n=60 participants at risk
Each subject received one 5-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 5 mg: Capsule for oral administration containing ACT-541468 at a strength of 5 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 10 mg
n=58 participants at risk
Each subject received one 10-mg ACT-541468 capusle (+ one placebo capsule), once daily in the evening for 4 weeks
ACT-541468 10 mg: Capsule for oral administration containing ACT-541468 at a strength of 10 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 25 mg
n=60 participants at risk
Each subject received one 25-mg ACT-541468 capsule (+ one placebo capsule), once daily in the evening) for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
ACT-541468 50 mg
n=61 participants at risk
Each subject received two 25-mg ACT-541468 capsules, once daily in the evening for 4 weeks
ACT-541468 25 mg: Capsule for oral administration containing ACT-541468 at a strength of 25 mg
|
Zolpidem
n=60 participants at risk
Each subject received one 10-mg zolpidem capsule (+ one placebo capusle), once daily in the evening for 4 weeks
Zolpidem: Over-encapsulated zolpidem tablet at a strength of 10 mg
Placebo 2: Placebo capsules matching over-encapsulated zolpidem
|
Placebo
n=60 participants at risk
Each subject received two placebo capsules, once daily in the evening for 4 weeks
Placebo 1: Placebo capsules matching ACT-541468 capsules
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Infections and infestations
Influenza
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Blood and lymphatic system disorders
Eosinophilia
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Cardiac disorders
Defect conduction intraventricular
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Cardiac disorders
Palpitations
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Ear and labyrinth disorders
Paraesthesia ear
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Eye disorders
Chromatopsia
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Eye disorders
Vision blurred
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
6.7%
4/60 • Number of events 5 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 3 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Gastrointestinal disorders
Diarrhoea
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
5.0%
3/60 • Number of events 3 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
3.3%
2/60 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Gastrointestinal disorders
Dry mouth
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Gastrointestinal disorders
Faeces pale
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Gastrointestinal disorders
Flatulence
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
3.3%
2/60 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
6.7%
4/60 • Number of events 5 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
General disorders
Chest discomfort
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
General disorders
Fatigue
|
1.7%
1/60 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
5.0%
3/60 • Number of events 3 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
6.7%
4/60 • Number of events 5 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
3.3%
2/60 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
General disorders
Feeling hot
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
General disorders
Gait disturbance
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
3.3%
2/60 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
General disorders
Influenza like illness
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
General disorders
Medical device site erythema
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
General disorders
Medical device site inflammation
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
General disorders
Medical device site irritation
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
General disorders
Medical device site pain
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
General disorders
Pyrexia
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Infections and infestations
Acute sinusitis
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Infections and infestations
Nasopharyngitis
|
3.3%
2/60 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
3.4%
2/58 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
3.3%
2/61 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
8.3%
5/60 • Number of events 5 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
6.7%
4/60 • Number of events 4 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Infections and infestations
Rash pustular
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Infections and infestations
Tooth infection
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
3.3%
2/60 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Investigations
Aspartate aminotransferase increased
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Investigations
Bilirubin conjugated increased
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Investigations
Blood calcium decreased
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
3.3%
2/60 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Investigations
Blood cholesterol increased
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Investigations
Blood creatine phosphokinase increased
|
3.3%
2/60 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Investigations
ECG signs of myocardial infarction
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Investigations
Electrocardiogram T wave inversion
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
3.3%
2/60 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Investigations
Weight increased
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Investigations
White blood cell count decreased
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Metabolism and nutrition disorders
Increased appetite
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Nervous system disorders
Balance disorder
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Nervous system disorders
Cervicobrachial syndrome
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Nervous system disorders
Dizziness
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
3.4%
2/58 • Number of events 4 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
6.7%
4/60 • Number of events 4 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Nervous system disorders
Dizziness postural
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Nervous system disorders
Headache
|
10.0%
6/60 • Number of events 7 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
8.6%
5/58 • Number of events 5 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
8.3%
5/60 • Number of events 5 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
8.2%
5/61 • Number of events 6 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
10.0%
6/60 • Number of events 8 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Nervous system disorders
Somnolence
|
5.0%
3/60 • Number of events 4 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
5.2%
3/58 • Number of events 3 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
6.7%
4/60 • Number of events 5 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
6.6%
4/61 • Number of events 5 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
5.0%
3/60 • Number of events 3 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
5.0%
3/60 • Number of events 3 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Psychiatric disorders
Abnormal dreams
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Psychiatric disorders
Nightmare
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Psychiatric disorders
Stress
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Renal and urinary disorders
Bladder discomfort
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Renal and urinary disorders
Renal pain
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.3%
2/60 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
3.3%
2/61 • Number of events 2 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.6%
1/61 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Surgical and medical procedures
Coronary arterial stent insertion
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/58 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
|
Vascular disorders
Hot flush
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/58 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/61 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
0.00%
0/60 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
1.7%
1/60 • Number of events 1 • Data on adverse events were collected from Screening to Safety Follow-up period. Below, data are reported for treatment-emergent adverse events (TEAEs).
|
Additional Information
Clinical Trial Disclosure Desk
Idorsia Pharmaceuticals
Phone: +41 588 441977
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place